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Review Panel
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Hematology
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Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
GMB
Light, Wood'S, Fluorescence
1
Product Code
GTL
Phages, Staphylococcal Typing, All Types
1
Product Code
JRZ
Media, Culture, Amino Acid Assay
1
Product Code
JSA
Culture Media, Antibiotic Assay
1
Product Code
JSB
Culture Media, Vitamin Assay
1
Product Code
JSC
Culture Media, General Nutrient Broth
1
Product Code
JSD
Culture Media, Selective Broth
1
Product Code
JSE
Culture Media, Multiple Biochemical Test
1
Product Code
JSF
Culture Media, Single Biochemical Test
1
Product Code
JSG
Culture Media, Non-Selective And Non-Differential
1
Product Code
JSH
Culture Media, Non-Selective And Differential
1
Product Code
JSI
Culture Media, Selective And Differential
1
Product Code
K
07
0691
BBL CHROMAGAR 0157
1
Cleared 510(K)
K
97
4428
DIPSTREAK
1
Cleared 510(K)
K
89
1593
LISTERIA SELECTIVE ENRICHMENT MEDIUM
1
Cleared 510(K)
K
89
0199
DENTOCULT SM-STRIP MUTANS
1
Cleared 510(K)
K
88
2182
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
1
Cleared 510(K)
K
88
1577
MODIFIED SELECTIVE STREPTOCOCCUS AGAR
1
Cleared 510(K)
K
88
1576
SELENITE BROTH
1
Cleared 510(K)
K
88
1575
SELECTIVE STREPTOCOCCUS AGAR
1
Cleared 510(K)
K
88
1572
XL AGAR BASE
1
Cleared 510(K)
K
88
1556
TRICHOMONAS BROTH
1
Cleared 510(K)
K
88
1555
TINSDALE AGAR BASE
1
Cleared 510(K)
K
88
0125
LOWENSTEIN-JENSEN, SELECTIVE
1
Cleared 510(K)
K
88
0108
CORN MEAL W/POLYSORBATE 80
1
Cleared 510(K)
K
88
0130
ATS MEDIA
1
Cleared 510(K)
K
88
0132
DERMATOPHYTE TEST MEDIUM
1
Cleared 510(K)
K
87
4344
QUAD PLATE (4 DIFFERENT MEDIA)
1
Cleared 510(K)
K
87
3259
SPECIALTY MEDIA
1
Cleared 510(K)
K
87
3260
CORYNEBACTERIA ISOLATION MEDIA
1
Cleared 510(K)
K
87
3258
STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA
1
Cleared 510(K)
K
87
3269
MYCOLOGICAL MEDIA
1
Cleared 510(K)
K
87
3264
MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS
1
Cleared 510(K)
K
87
3261
ENTERIC ISOLATION MEDIA
1
Cleared 510(K)
K
87
3265
MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION
1
Cleared 510(K)
K
87
3262
DIFFERENTIAL MEDIA
1
Cleared 510(K)
K
87
3481
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016
1
Cleared 510(K)
K
87
3329
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
1
Cleared 510(K)
K
87
3228
LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507
1
Cleared 510(K)
K
87
3223
MACCONKEY AGAR - PRODUCT #P1606
1
Cleared 510(K)
K
87
3225
EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309
1
Cleared 510(K)
K
87
3226
XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601
1
Cleared 510(K)
K
87
3227
MANNITOL SALT AGAR (MSA) PRODUCT #P1706
1
Cleared 510(K)
K
87
2301
DENTOCULT-SM CULTURE-PADDLE
1
Cleared 510(K)
K
87
3055
MACCONKEY AGAR - PRODUCT #P1606
1
Cleared 510(K)
K
87
2683
IAFP BILE ESCULIN AGAR
1
Cleared 510(K)
K
87
2669
IAFP X.L.D. AGAR
1
Cleared 510(K)
K
87
2682
IAFP S.S. AGAR
1
Cleared 510(K)
K
87
2675
IAFP MANNITOL NACL
1
Cleared 510(K)
K
87
2672
IAFP BILE ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
87
2956
SORBITOL MACCONKEY AGAR NO. 3 CM 813
1
Cleared 510(K)
K
87
2188
MACCONKEY W/SORBITOL
1
Cleared 510(K)
K
87
2058
ORICULT-N CULTURE-PADDLE
1
Cleared 510(K)
K
87
0640
CETRIMIDE SELECTIVE AGAR
1
Cleared 510(K)
K
87
0648
STAPHYLOCOCCUS 110 AGAR
1
Cleared 510(K)
K
87
0644
BRILLIANT GREEN AGAR
1
Cleared 510(K)
K
87
0643
POTATO DEXTROSE AGAR
1
Cleared 510(K)
K
87
0638
BACTEROIDES BILE ESCULIN AGAR
1
Cleared 510(K)
K
87
1094
BRILLIANT GREEN AGAR
1
Cleared 510(K)
K
87
1088
ANAEROBIC LKV BLOOD AGAR
1
Cleared 510(K)
K
86
4242
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
86
4243
MACCONKEY AGAR
1
Cleared 510(K)
K
87
0502
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
1
Cleared 510(K)
K
87
0340
Z2017, BEA/CNA 5%SB BIPLATE
1
Cleared 510(K)
K
87
0339
P4802 BEA
1
Cleared 510(K)
K
87
0341
P1012 BE AGAR
1
Cleared 510(K)
K
87
0057
T1365 (BIRD SEED AGAR SLANT)
1
Cleared 510(K)
K
86
4764
CULTURIA MACCONKEY-MUG/CLED SYSTEMS
1
Cleared 510(K)
K
86
4077
CANDIDA BROM CRESOL GREEN AGAR
1
Cleared 510(K)
K
86
3519
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR
1
Cleared 510(K)
K
86
3525
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
1
Cleared 510(K)
K
85
4672
CANDI-KIT TM
1
Cleared 510(K)
K
86
2391
BIOTIS DESOXYCHOLATE AGAR
1
Cleared 510(K)
K
86
2389
BIOTIS ACETAMIDE AGAR
1
Cleared 510(K)
K
86
2394
BIOTIS MITIS SALIVARIUS
1
Cleared 510(K)
K
86
2388
BIOTIS TCBS AGAR
1
Cleared 510(K)
K
86
2425
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
1
Cleared 510(K)
K
86
0707
OFPBL
1
Cleared 510(K)
K
86
0385
BIOTIS MAC-MUG
1
Cleared 510(K)
K
86
0386
BIOTIS SF BROTH
1
Cleared 510(K)
K
86
0388
BIOTIS KF STREPTOCOCCUS AGAR
1
Cleared 510(K)
K
86
0402
BIOTIS BISMUTH SULFITE AGAR
1
Cleared 510(K)
K
85
5205
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
1
Cleared 510(K)
K
85
5110
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
1
Cleared 510(K)
K
85
4452
MANNITOL SALT AGAR
1
Cleared 510(K)
K
85
4450
BILE ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
85
4449
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
85
3691
TERGITOL 7 AGAR
1
Cleared 510(K)
K
85
3617
APL SIMMONS CITRATE AGAR
1
Cleared 510(K)
K
85
3611
APL XYLOSE LYSINE DEOXYCHOLATE AGAR
1
Cleared 510(K)
K
85
3488
STAPH KIT
1
Cleared 510(K)
K
85
3228
APL SALMONELLA-SHIGELLA AGAR
1
Cleared 510(K)
K
85
3225
APL LEVINE EMB AGAR
1
Cleared 510(K)
K
85
3226
APL BIGGY AGAR(NICKERSON)
1
Cleared 510(K)
K
85
3229
APL 6.5% SODIUM CHLORIDE BROTH
1
Cleared 510(K)
K
85
3232
APL MANNITOL SALT AGAR
1
Cleared 510(K)
K
85
3234
APL MACCONKEY AGAR
1
Cleared 510(K)
K
85
3235
APL HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
85
2789
AEROMONAS AGAR(XDCA)
1
Cleared 510(K)
K
85
2480
DERM-KIT
1
Cleared 510(K)
K
85
1594
SF BROTH
1
Cleared 510(K)
K
85
1577
BILE ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
85
1578
BILE ESCULIN AGAR
1
Cleared 510(K)
K
85
1603
XYLOSE LYSINE DESOXYCHOLATE AGAR
1
Cleared 510(K)
K
85
1583
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
85
1581
DERMATOPHYTE TEST MEDIUM
1
Cleared 510(K)
K
85
1585
MANNITOL SALT AGAR
1
Cleared 510(K)
K
85
1586
MACCONKEY AGAR
1
Cleared 510(K)
K
85
1584
LEVINE EMB AGAR
1
Cleared 510(K)
K
85
0723
SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC
1
Cleared 510(K)
K
85
0720
EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
1
Cleared 510(K)
K
85
0736
SELECTIVE CULTURE MEDIUM
1
Cleared 510(K)
K
85
0565
BIOTIS CHOCOLATE TELLURITE
1
Cleared 510(K)
K
85
0552
BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE
1
Cleared 510(K)
K
84
4933
BILE ESCULIN AGAR
1
Cleared 510(K)
K
84
4930
BRILLANT GREEN AGAR
1
Cleared 510(K)
K
84
4934
AZIDE AGAR W/5% SHEEP BLOOD
1
Cleared 510(K)
K
84
4515
VIOLET RED BILE AGAR
1
Cleared 510(K)
K
84
4535
YERSINIA SELECTIVE AGAR
1
Cleared 510(K)
K
84
4195
BIOTIS ANAEROBIC KBE AGAR
1
Cleared 510(K)
K
83
4423
S S AGAR PLATE
1
Cleared 510(K)
K
83
4420
MANNITOL-SALT AGAR USP PLATE
1
Cleared 510(K)
K
84
3761
BIOTIS BIGGY AGAR & BIGGY SLANT
1
Cleared 510(K)
K
84
3762
BIOTIS EMB-LEVINE AGAR
1
Cleared 510(K)
K
84
3763
BIOTIS EMB AGAR HOLT-HARRIS
1
Cleared 510(K)
K
84
3767
BIOTIS UREA AGAR
1
Cleared 510(K)
K
84
3492
NEOMYCIN BLOOD AGAR
1
Cleared 510(K)
K
84
3193
STREP SELECTIVE II
1
Cleared 510(K)
K
84
3194
V AGAR SELECTIVE DEEPS
1
Cleared 510(K)
K
84
3066
BIOTIS CIN AGAR PLATES
1
Cleared 510(K)
K
84
2100
MACCONKEY AGAR, PLUS
1
Cleared 510(K)
K
84
2101
COBA AGAR
1
Cleared 510(K)
K
84
1753
MACCONKEY AGAR
1
Cleared 510(K)
K
84
1747
MANNITOL SALT AGAR
1
Cleared 510(K)
K
84
1752
XYLOSE-LYSINE DESOXYCHOLATE AGAR
1
Cleared 510(K)
K
84
1751
LEVINE EOSIN METHYLENE BLUE AGAR
1
Cleared 510(K)
K
84
1844
DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR
1
Cleared 510(K)
K
84
1842
DIFFERENTIAL CULTURE MED. MACCONKEY AGAR
1
Cleared 510(K)
K
84
1841
DIFFERENTIAL CULTURE MED. MANNITOL SALT
1
Cleared 510(K)
K
84
1745
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
84
1304
HAEMOPHILUS ID QUAD-PLATE
1
Cleared 510(K)
K
84
1209
SELECTIVE AND DIFFERENTIAL
1
Cleared 510(K)
K
84
1207
NON-SELECTIVE & NON-DIFFERENTIAL
1
Cleared 510(K)
K
84
0338
HAEMOPHILUS I.D. II TRIPLATE
1
Cleared 510(K)
K
84
1218
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR
1
Cleared 510(K)
K
84
1142
LEVINE EOSIN METHYLENE BLUE AGAR
1
Cleared 510(K)
K
84
1222
BACTEROIDES BILE ESCULIN GAR
1
Cleared 510(K)
K
84
1141
MACCONKEY AGAR
1
Cleared 510(K)
K
84
1134
MANNITOL SALT AGAR
1
Cleared 510(K)
K
84
1129
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
84
1132
EILE-ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
84
1131
XYLOSE LYSINE DESOXYCHOLATE AGAR
1
Cleared 510(K)
K
84
0889
CLOSTRIDIUM DIFFICILE AGAR DEEP &
1
Cleared 510(K)
K
84
0615
YERSINIA SUPPLEMENT
1
Cleared 510(K)
K
84
0160
B-STREP-TECT-II
1
Cleared 510(K)
K
84
0294
GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
1
Cleared 510(K)
K
84
0190
MACCONKEY AGAR W/TWEEN 80 & AMPICIL
1
Cleared 510(K)
K
83
4320
TCBS
1
Cleared 510(K)
K
83
4019
BIGGY AGAR NICKERSON MEDIUM
1
Cleared 510(K)
K
83
3508
PREPARED MACCONKEY AGAR
1
Cleared 510(K)
K
83
3301
FEELEY-GORMAN AGAR
1
Cleared 510(K)
K
83
3254
STREPTOCOCCUS ID TRIPLATE SYSTEM
1
Cleared 510(K)
K
83
3219
STAPHYLOCOCCUS AGAR 10
1
Cleared 510(K)
K
83
3212
MAC CONKEY AGAR WITHOUT CRYSTAL VIOLET
1
Cleared 510(K)
K
83
3205
YERSINIA SELECTIVE AGAR
1
Cleared 510(K)
K
83
3204
DEOXYCHOLATE CITRATE AGAR
1
Cleared 510(K)
K
83
3203
DEOXYCHOLATE LACTOSE AGAR
1
Cleared 510(K)
K
83
2523
TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE
1
Cleared 510(K)
K
83
2524
BAIRD PARKER AGAR PLATE
1
Cleared 510(K)
K
83
2535
HEKTOEN ENTERIC AGAR PLATE
1
Cleared 510(K)
K
83
2954
V AGAR
1
Cleared 510(K)
K
83
2955
BACTEROIDES BILE ESCULIN AGAR
1
Cleared 510(K)
K
83
2863
STREP ID QUAD
1
Cleared 510(K)
K
83
2571
BILE ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
83
2572
BILE ESCULIN AGAR
1
Cleared 510(K)
K
83
2617
XYLOSE LYSINE DEOXYCHOLATE
1
Cleared 510(K)
K
83
2618
BLUE AGAR
1
Cleared 510(K)
K
83
2365
TCBS AGAR
1
Cleared 510(K)
K
83
0251
CAMPY BLOOD AGAR PLATE
1
Cleared 510(K)
K
83
0065
SALMONELLA-SHIGELLA AGAR
1
Cleared 510(K)
K
83
0082
BIGGY AGAR
1
Cleared 510(K)
K
83
0071
MACCONKEY AGAR
1
Cleared 510(K)
K
83
0079
BISMUTH SULFITE AGAR
1
Cleared 510(K)
K
83
0072
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
83
0070
MANNITOL SALT AGAR
1
Cleared 510(K)
K
83
0064
XLD AGAR
1
Cleared 510(K)
K
82
3310
STREPTOCOCCUS SELECTIVE AGAR
1
Cleared 510(K)
K
82
3307
CAMPYLOBACTER SELECTIVE AGAR
1
Cleared 510(K)
K
82
3306
HEMOPHILUS QUAD 10 PLATE
1
Cleared 510(K)
K
82
3122
LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM
1
Cleared 510(K)
K
82
2737
MYCOTRIUM-RS
1
Cleared 510(K)
K
82
2736
MYCOTRIUM-GU
1
Cleared 510(K)
K
82
2997
STREP SELECTIVE AGAR
1
Cleared 510(K)
K
82
2855
YERSINIA ISOLATION MEDIUM
1
Cleared 510(K)
K
82
1605
XYLOSE LYSINE DEOXYCHOLATE AGAR
1
Cleared 510(K)
K
82
1608
CNA/VAGINALIS AGAR
1
Cleared 510(K)
K
82
1775
TERGITOL 7 AGAR WITH TTC
1
Cleared 510(K)
K
82
1300
#2010 CAMPHYLOBACTER AGAR
1
Cleared 510(K)
K
82
1427
MANNITOL SALT AGAR
1
Cleared 510(K)
K
82
1420
EMB AGAR
1
Cleared 510(K)
K
82
1419
EMB AGAR
1
Cleared 510(K)
K
82
1431
XLD AGAR
1
Cleared 510(K)
K
82
1426
STAPHYLOCOCCUS MEDIUM 1100
1
Cleared 510(K)
K
82
1423
MACCONKEY AGAR
1
Cleared 510(K)
K
82
1422
SS AGAR
1
Cleared 510(K)
K
82
1421
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
82
1301
#50002 QUAD DIAGNOSTIC SYSTEM
1
Cleared 510(K)
K
82
1108
BI PLATE-XLD/HEKTOEN #30012
1
Cleared 510(K)
K
82
0844
CULTURE MEDIA, SELECTIVE & DIFFERENTIAL
1
Cleared 510(K)
K
82
0800
#2006 SALMONELLA SHIGELLA AGAR
1
Cleared 510(K)
K
82
0802
#2009 BIGGY AGAR
1
Cleared 510(K)
K
82
0797
#50001 QUADE DIAGNOSTIC SYSTEM
1
Cleared 510(K)
K
82
0798
#2001 HEKTOEN
1
Cleared 510(K)
K
82
0801
#2007 XLD
1
Cleared 510(K)
K
82
0553
BILE ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
82
0552
EOSIN METHYLENE BLUE AGAR
1
Cleared 510(K)
K
81
2731
SEPTI-CHECK BLOOD CULTURE SLIDE
1
Cleared 510(K)
K
81
2187
SMITH'S SYSTEMIC FUNGAL MEDIUM
1
Cleared 510(K)
K
81
1648
ENDO AGAR
1
Cleared 510(K)
K
81
1644
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
81
1642
EOSIN METHYLENE BLUE AGAR (LEVINE)
1
Cleared 510(K)
K
81
1643
MACCONKEY AGAR
1
Cleared 510(K)
K
81
1647
SALMONELLA-SHIGELLA AGAR
1
Cleared 510(K)
K
81
1598
DNASE AGAR MEDIA
1
Cleared 510(K)
K
81
1611
MACCONKEY AGAR
1
Cleared 510(K)
K
81
1610
EOSIN METHYLENE BLUE AGAR (LEVINE)
1
Cleared 510(K)
K
81
1609
MANNITOL SALT AGAR
1
Cleared 510(K)
K
81
1605
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
81
1604
XYLOSE LYSINE DEOXYCHOLATE AGAR
1
Cleared 510(K)
K
81
1603
SALMONELLA SHIGELLA AGAR
1
Cleared 510(K)
K
81
1600
BILE ESCULIN MEDIA
1
Cleared 510(K)
K
81
1599
EOSIN METHYLENE BLUE AGAR
1
Cleared 510(K)
K
81
1514
BACILLUS CEREUS SELECTIVE(AGAR&SUPP)
1
Cleared 510(K)
K
81
1477
MACCONKEY AGAR
1
Cleared 510(K)
K
81
1478
EMB AGAR, LEVINE
1
Cleared 510(K)
K
81
1474
TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB
1
Cleared 510(K)
K
81
1422
STREP-ID PLATE
1
Cleared 510(K)
K
81
1420
MINERALS MODIFIED MED. BASE & SOD. GLUT.
1
Cleared 510(K)
K
81
1362
TCBS AGAR
1
Cleared 510(K)
K
81
1355
LYSINE IRON AGAR
1
Cleared 510(K)
K
81
1332
BRAIN HEART CC AGAR
1
Cleared 510(K)
K
81
1338
VIOLET RED BILE AGAR
1
Cleared 510(K)
K
81
1334
MYCOSEL
1
Cleared 510(K)
K
81
1331
SF BROTH
1
Cleared 510(K)
K
81
1327
SALMONELLA SHIGELLA AGAR
1
Cleared 510(K)
K
81
1324
PHENYLETHANOL AGAR
1
Cleared 510(K)
K
81
1131
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
81
1134
ACU-DESOXYCHOLATE AGAR
1
Cleared 510(K)
K
81
1133
EOSIN-METHYLENE BLUE AGAR
1
Cleared 510(K)
K
81
1129
LAURYL SULFATE BROTH
1
Cleared 510(K)
K
81
1041
BRILLIANT GREEN AGAR
1
Cleared 510(K)
K
81
1039
VOGEL & JOHNSON AGAR
1
Cleared 510(K)
K
81
1048
MACCONKEY AGAR
1
Cleared 510(K)
K
81
1046
STERILITY TEST BROTH
1
Cleared 510(K)
K
81
1045
LEVIN EOSIN-METHYLENE BLUE AGAR
1
Cleared 510(K)
K
81
1043
BISMUTH SULFITE AGAR
1
Cleared 510(K)
K
81
1042
XLD AGAR
1
Cleared 510(K)
K
81
1040
CETRIMEDE AGAR
1
Cleared 510(K)
K
81
1054
BIGGY AGAR
1
Cleared 510(K)
K
81
1038
BAIRD-PARKER AGAR
1
Cleared 510(K)
K
81
1037
MANNITAL SALT AGAR
1
Cleared 510(K)
K
81
0933
VOTEL-JOHNSON AGAR (MODIFIED)
1
Cleared 510(K)
K
81
0931
SS AGAR (MODIFIED)
1
Cleared 510(K)
K
81
0929
PERFRINGENS AGAR BASE
1
Cleared 510(K)
K
80
2947
ORICULT DTM
1
Cleared 510(K)
K
80
0980
HEXTOEN ENTERIC AGAR
1
Cleared 510(K)
K
80
0983
MACCONKEY AGAR
1
Cleared 510(K)
K
80
0745
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
1
Cleared 510(K)
K
80
0157
BISMUTH SULFITE AGAR
1
Cleared 510(K)
K
79
2424
CHOCOLATE TELLURITE AGAR
1
Cleared 510(K)
K
79
1942
BILE ESCULIN AZIDE AGAR
1
Cleared 510(K)
K
79
1940
UREA AGAR
1
Cleared 510(K)
K
79
1414
DTM (DERMATOPHYTE TEST MEDIUM) AGAR
1
Cleared 510(K)
K
79
1786
SALMONELLA SHIGELLA AGAR PLATE
1
Cleared 510(K)
K
79
1816
DC AGAR (DESOXYCHOLATE CITRATE AGAR)
1
Cleared 510(K)
K
79
1785
MEKTOEN ENTERIC AGAR 100X15MM PLATE
1
Cleared 510(K)
K
79
1787
XYLOSE LYSINE DESOXYCHOLATE AGAR PLATE
1
Cleared 510(K)
K
79
1627
MANNITOL SALT AGAR
1
Cleared 510(K)
K
79
1621
MANNITOL SALT AGAR
1
Cleared 510(K)
K
79
1555
LEVINE EOSIN METHYLER
1
Cleared 510(K)
K
79
1579
ANAEROBIC BRUCELLA BLOOD AGAR
1
Cleared 510(K)
K
79
1563
ANAEROBIC BRUCELLA LAKED BLOOD AGAR
1
Cleared 510(K)
K
79
1479
ENDO AGAR
1
Cleared 510(K)
K
79
1477
XLD AGAR (XYLASE LYSINE DESOXY AGAR)
1
Cleared 510(K)
K
79
1475
HEKTOEN ENTERIC AGAR
1
Cleared 510(K)
K
79
1518
BIGGY AGAR
1
Cleared 510(K)
K
79
1520
EMB AGAR (EOSIN METHYLENE BLUE AGAR)
1
Cleared 510(K)
K
79
1519
LEVINE EMB AGAR
1
Cleared 510(K)
K
79
1480
SS AGAR (SALMONELLA SHIGELLA AGAR)
1
Cleared 510(K)
K
79
1482
MACCONKEY MEDIA
1
Cleared 510(K)
K
79
1472
PHENYLETHANOL AGAG (PEA)
1
Cleared 510(K)
K
79
0624
LOMBARD-DOWELL BROTH MEDIUM W/LACTATE
1
Cleared 510(K)
K
79
0628
LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR
1
Cleared 510(K)
K
79
0469
STREP BLOOD AGAR-5% SHEEP BLOOD
1
Cleared 510(K)
K
79
0119
C/N SCREEN
1
Cleared 510(K)
K
78
0704
COLUMBIA AGAR WITH 5% RABBIT BLOOD
1
Cleared 510(K)
K
77
1647
JEMBEC-CVSB PLATE
1
Cleared 510(K)
JSJ
Culture Media, Selective And Non-Differential
1
Product Code
JSK
Supplement, Culture Media
1
Product Code
JSL
Culture Media, Anaerobic Transport
1
Product Code
JSM
Culture Media, Non-Propagating Transport
1
Product Code
JSN
Culture Media, Propagating Transport
1
Product Code
JSP
Kit, Anaerobic Identification
1
Product Code
JSR
Kit, Identification, Dermatophyte
1
Product Code
JSS
Kit, Identification, Enterobacteriaceae
1
Product Code
JST
Kit, Fastidious Organisms
1
Product Code
JSW
Kit, Identification, Glucose Nonfermenter
1
Product Code
JSX
Kit, Identification, Neisseria Gonorrhoeae
1
Product Code
JSY
Kit, Identification, Mycobacteria
1
Product Code
JSZ
Kit, Identification, Pseudomonas
1
Product Code
JTA
Monitor, Microbial Growth
1
Product Code
JTB
Device, Media Dispensing/Stacking
1
Product Code
JTC
Device, Microtiter Diluting/Dispensing
1
Product Code
JTL
Plasma, Coagulase, Human, Horse And Rabbit
1
Product Code
JTM
Anaerobic Box Glove
1
Product Code
JTO
Discs, Strips And Reagents, Microorganism Differentiation
1
Product Code
JTQ
Bath, Incubators/Water, All
1
Product Code
JTR
Kit, Quality Control For Culture Media
1
Product Code
JTW
System, Transport, Aerobic
1
Product Code
JTX
Transport Systems, Anaerobic
1
Product Code
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
2
Product Code
JWX
Kit, Screening, Staphylococcus Aureus
1
Product Code
JWZ
Kit, Screening, Trichomonas
1
Product Code
JXA
Kit, Screening, Urine
1
Product Code
JXB
Kit, Identification, Yeast
1
Product Code
JXC
Kit, Screening, Yeast
1
Product Code
KZB
Automated Colony Counter
1
Product Code
KZC
Manual Colony Counter
1
Product Code
KZI
Culture Media, Enriched
1
Product Code
KZJ
Device, Gas Generating
1
Product Code
KZK
Reader, Zone, Automated
1
Product Code
LGA
Device, Oxidase Test For Gonorrhea
3
Product Code
LIB
Device, General Purpose, Microbiology, Diagnostic
1
Product Code
LIO
Device, Specimen Collection
1
Product Code
LJF
Device, Antimicrobial Drug Removal
1
Product Code
LJG
Quality Control Slides
1
Product Code
LKS
Device, Parasite Concentration
1
Product Code
LLH
Reagents, Clostridium Difficile Toxin
1
Product Code
LQL
Gram Positive Identification Panel
1
Product Code
LQM
Gram Negative Identification Panel
1
Product Code
LRH
Instrument For Auto Reader Of Overnight Microorganism Identification System
1
Product Code
LSC
Neisseria Controls
1
Product Code
LTS
Test Reagents, Neisseria Gonorrhoeae Biochemical
1
Product Code
MCB
Antigen, C. Difficile
1
Product Code
MDB
System, Blood Culturing
1
Product Code
MJK
Dna Probe, Trichomonas Vaginalis
1
Product Code
MJM
Dna Probe, Gardnerella Vaginalis
1
Product Code
MLA
Dna Probe, Yeast
1
Product Code
NZS
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
1
Product Code
OMN
C. Difficile Nucleic Acid Amplification Test Assay
1
Product Code
OUS
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
1
Product Code
PGX
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
2
Product Code
PPU
Microbial Colony Image Assessment System
2
Product Code
PQZ
Gbs Culture Media, Selective And Differential
1
Product Code
QBD
Microbial Nucleic Acid Storage And Stabilization Device
2
Product Code
QBQ
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
1
Product Code
QMC
Transport Medium, Notified Per The Vtm Guidance
1
Product Code
QQY
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
2
Product Code
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 11 July 2025 at 11:06 pm
MI
/
subpart-c—microbiology-devices
/
JSI
/
K791785
View Source
MEKTOEN ENTERIC AGAR 100X15MM PLATE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K791785
510(k) Type
Traditional
Applicant
AMERICAN LABORATORY SUPPLY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1979
Days to Decision
20 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
GMB
Light, Wood'S, Fluorescence
GTL
Phages, Staphylococcal Typing, All Types
JRZ
Media, Culture, Amino Acid Assay
JSA
Culture Media, Antibiotic Assay
JSB
Culture Media, Vitamin Assay
JSC
Culture Media, General Nutrient Broth
JSD
Culture Media, Selective Broth
JSE
Culture Media, Multiple Biochemical Test
JSF
Culture Media, Single Biochemical Test
JSG
Culture Media, Non-Selective And Non-Differential
JSH
Culture Media, Non-Selective And Differential
JSI
Culture Media, Selective And Differential
K
07
0691
BBL CHROMAGAR 0157
K
97
4428
DIPSTREAK
K
89
1593
LISTERIA SELECTIVE ENRICHMENT MEDIUM
K
89
0199
DENTOCULT SM-STRIP MUTANS
K
88
2182
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
K
88
1577
MODIFIED SELECTIVE STREPTOCOCCUS AGAR
K
88
1576
SELENITE BROTH
K
88
1575
SELECTIVE STREPTOCOCCUS AGAR
K
88
1572
XL AGAR BASE
K
88
1556
TRICHOMONAS BROTH
K
88
1555
TINSDALE AGAR BASE
K
88
0125
LOWENSTEIN-JENSEN, SELECTIVE
K
88
0108
CORN MEAL W/POLYSORBATE 80
K
88
0130
ATS MEDIA
K
88
0132
DERMATOPHYTE TEST MEDIUM
K
87
4344
QUAD PLATE (4 DIFFERENT MEDIA)
K
87
3259
SPECIALTY MEDIA
K
87
3260
CORYNEBACTERIA ISOLATION MEDIA
K
87
3258
STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA
K
87
3269
MYCOLOGICAL MEDIA
K
87
3264
MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS
K
87
3261
ENTERIC ISOLATION MEDIA
K
87
3265
MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION
K
87
3262
DIFFERENTIAL MEDIA
K
87
3481
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016
K
87
3329
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
K
87
3228
LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507
K
87
3223
MACCONKEY AGAR - PRODUCT #P1606
K
87
3225
EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309
K
87
3226
XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601
K
87
3227
MANNITOL SALT AGAR (MSA) PRODUCT #P1706
K
87
2301
DENTOCULT-SM CULTURE-PADDLE
K
87
3055
MACCONKEY AGAR - PRODUCT #P1606
K
87
2683
IAFP BILE ESCULIN AGAR
K
87
2669
IAFP X.L.D. AGAR
K
87
2682
IAFP S.S. AGAR
K
87
2675
IAFP MANNITOL NACL
K
87
2672
IAFP BILE ESCULIN AZIDE AGAR
K
87
2956
SORBITOL MACCONKEY AGAR NO. 3 CM 813
K
87
2188
MACCONKEY W/SORBITOL
K
87
2058
ORICULT-N CULTURE-PADDLE
K
87
0640
CETRIMIDE SELECTIVE AGAR
K
87
0648
STAPHYLOCOCCUS 110 AGAR
K
87
0644
BRILLIANT GREEN AGAR
K
87
0643
POTATO DEXTROSE AGAR
K
87
0638
BACTEROIDES BILE ESCULIN AGAR
K
87
1094
BRILLIANT GREEN AGAR
K
87
1088
ANAEROBIC LKV BLOOD AGAR
K
86
4242
HEKTOEN ENTERIC AGAR
K
86
4243
MACCONKEY AGAR
K
87
0502
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
K
87
0340
Z2017, BEA/CNA 5%SB BIPLATE
K
87
0339
P4802 BEA
K
87
0341
P1012 BE AGAR
K
87
0057
T1365 (BIRD SEED AGAR SLANT)
K
86
4764
CULTURIA MACCONKEY-MUG/CLED SYSTEMS
K
86
4077
CANDIDA BROM CRESOL GREEN AGAR
K
86
3519
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR
K
86
3525
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
K
85
4672
CANDI-KIT TM
K
86
2391
BIOTIS DESOXYCHOLATE AGAR
K
86
2389
BIOTIS ACETAMIDE AGAR
K
86
2394
BIOTIS MITIS SALIVARIUS
K
86
2388
BIOTIS TCBS AGAR
K
86
2425
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
K
86
0707
OFPBL
K
86
0385
BIOTIS MAC-MUG
K
86
0386
BIOTIS SF BROTH
K
86
0388
BIOTIS KF STREPTOCOCCUS AGAR
K
86
0402
BIOTIS BISMUTH SULFITE AGAR
K
85
5205
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
K
85
5110
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K
85
4452
MANNITOL SALT AGAR
K
85
4450
BILE ESCULIN AZIDE AGAR
K
85
4449
HEKTOEN ENTERIC AGAR
K
85
3691
TERGITOL 7 AGAR
K
85
3617
APL SIMMONS CITRATE AGAR
K
85
3611
APL XYLOSE LYSINE DEOXYCHOLATE AGAR
K
85
3488
STAPH KIT
K
85
3228
APL SALMONELLA-SHIGELLA AGAR
K
85
3225
APL LEVINE EMB AGAR
K
85
3226
APL BIGGY AGAR(NICKERSON)
K
85
3229
APL 6.5% SODIUM CHLORIDE BROTH
K
85
3232
APL MANNITOL SALT AGAR
K
85
3234
APL MACCONKEY AGAR
K
85
3235
APL HEKTOEN ENTERIC AGAR
K
85
2789
AEROMONAS AGAR(XDCA)
K
85
2480
DERM-KIT
K
85
1594
SF BROTH
K
85
1577
BILE ESCULIN AZIDE AGAR
K
85
1578
BILE ESCULIN AGAR
K
85
1603
XYLOSE LYSINE DESOXYCHOLATE AGAR
K
85
1583
HEKTOEN ENTERIC AGAR
K
85
1581
DERMATOPHYTE TEST MEDIUM
K
85
1585
MANNITOL SALT AGAR
K
85
1586
MACCONKEY AGAR
K
85
1584
LEVINE EMB AGAR
K
85
0723
SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC
K
85
0720
EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
K
85
0736
SELECTIVE CULTURE MEDIUM
K
85
0565
BIOTIS CHOCOLATE TELLURITE
K
85
0552
BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE
K
84
4933
BILE ESCULIN AGAR
K
84
4930
BRILLANT GREEN AGAR
K
84
4934
AZIDE AGAR W/5% SHEEP BLOOD
K
84
4515
VIOLET RED BILE AGAR
K
84
4535
YERSINIA SELECTIVE AGAR
K
84
4195
BIOTIS ANAEROBIC KBE AGAR
K
83
4423
S S AGAR PLATE
K
83
4420
MANNITOL-SALT AGAR USP PLATE
K
84
3761
BIOTIS BIGGY AGAR & BIGGY SLANT
K
84
3762
BIOTIS EMB-LEVINE AGAR
K
84
3763
BIOTIS EMB AGAR HOLT-HARRIS
K
84
3767
BIOTIS UREA AGAR
K
84
3492
NEOMYCIN BLOOD AGAR
K
84
3193
STREP SELECTIVE II
K
84
3194
V AGAR SELECTIVE DEEPS
K
84
3066
BIOTIS CIN AGAR PLATES
K
84
2100
MACCONKEY AGAR, PLUS
K
84
2101
COBA AGAR
K
84
1753
MACCONKEY AGAR
K
84
1747
MANNITOL SALT AGAR
K
84
1752
XYLOSE-LYSINE DESOXYCHOLATE AGAR
K
84
1751
LEVINE EOSIN METHYLENE BLUE AGAR
K
84
1844
DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR
K
84
1842
DIFFERENTIAL CULTURE MED. MACCONKEY AGAR
K
84
1841
DIFFERENTIAL CULTURE MED. MANNITOL SALT
K
84
1745
HEKTOEN ENTERIC AGAR
K
84
1304
HAEMOPHILUS ID QUAD-PLATE
K
84
1209
SELECTIVE AND DIFFERENTIAL
K
84
1207
NON-SELECTIVE & NON-DIFFERENTIAL
K
84
0338
HAEMOPHILUS I.D. II TRIPLATE
K
84
1218
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR
K
84
1142
LEVINE EOSIN METHYLENE BLUE AGAR
K
84
1222
BACTEROIDES BILE ESCULIN GAR
K
84
1141
MACCONKEY AGAR
K
84
1134
MANNITOL SALT AGAR
K
84
1129
HEKTOEN ENTERIC AGAR
K
84
1132
EILE-ESCULIN AZIDE AGAR
K
84
1131
XYLOSE LYSINE DESOXYCHOLATE AGAR
K
84
0889
CLOSTRIDIUM DIFFICILE AGAR DEEP &
K
84
0615
YERSINIA SUPPLEMENT
K
84
0160
B-STREP-TECT-II
K
84
0294
GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
K
84
0190
MACCONKEY AGAR W/TWEEN 80 & AMPICIL
K
83
4320
TCBS
K
83
4019
BIGGY AGAR NICKERSON MEDIUM
K
83
3508
PREPARED MACCONKEY AGAR
K
83
3301
FEELEY-GORMAN AGAR
K
83
3254
STREPTOCOCCUS ID TRIPLATE SYSTEM
K
83
3219
STAPHYLOCOCCUS AGAR 10
K
83
3212
MAC CONKEY AGAR WITHOUT CRYSTAL VIOLET
K
83
3205
YERSINIA SELECTIVE AGAR
K
83
3204
DEOXYCHOLATE CITRATE AGAR
K
83
3203
DEOXYCHOLATE LACTOSE AGAR
K
83
2523
TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE
K
83
2524
BAIRD PARKER AGAR PLATE
K
83
2535
HEKTOEN ENTERIC AGAR PLATE
K
83
2954
V AGAR
K
83
2955
BACTEROIDES BILE ESCULIN AGAR
K
83
2863
STREP ID QUAD
K
83
2571
BILE ESCULIN AZIDE AGAR
K
83
2572
BILE ESCULIN AGAR
K
83
2617
XYLOSE LYSINE DEOXYCHOLATE
K
83
2618
BLUE AGAR
K
83
2365
TCBS AGAR
K
83
0251
CAMPY BLOOD AGAR PLATE
K
83
0065
SALMONELLA-SHIGELLA AGAR
K
83
0082
BIGGY AGAR
K
83
0071
MACCONKEY AGAR
K
83
0079
BISMUTH SULFITE AGAR
K
83
0072
HEKTOEN ENTERIC AGAR
K
83
0070
MANNITOL SALT AGAR
K
83
0064
XLD AGAR
K
82
3310
STREPTOCOCCUS SELECTIVE AGAR
K
82
3307
CAMPYLOBACTER SELECTIVE AGAR
K
82
3306
HEMOPHILUS QUAD 10 PLATE
K
82
3122
LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM
K
82
2737
MYCOTRIUM-RS
K
82
2736
MYCOTRIUM-GU
K
82
2997
STREP SELECTIVE AGAR
K
82
2855
YERSINIA ISOLATION MEDIUM
K
82
1605
XYLOSE LYSINE DEOXYCHOLATE AGAR
K
82
1608
CNA/VAGINALIS AGAR
K
82
1775
TERGITOL 7 AGAR WITH TTC
K
82
1300
#2010 CAMPHYLOBACTER AGAR
K
82
1427
MANNITOL SALT AGAR
K
82
1420
EMB AGAR
K
82
1419
EMB AGAR
K
82
1431
XLD AGAR
K
82
1426
STAPHYLOCOCCUS MEDIUM 1100
K
82
1423
MACCONKEY AGAR
K
82
1422
SS AGAR
K
82
1421
HEKTOEN ENTERIC AGAR
K
82
1301
#50002 QUAD DIAGNOSTIC SYSTEM
K
82
1108
BI PLATE-XLD/HEKTOEN #30012
K
82
0844
CULTURE MEDIA, SELECTIVE & DIFFERENTIAL
K
82
0800
#2006 SALMONELLA SHIGELLA AGAR
K
82
0802
#2009 BIGGY AGAR
K
82
0797
#50001 QUADE DIAGNOSTIC SYSTEM
K
82
0798
#2001 HEKTOEN
K
82
0801
#2007 XLD
K
82
0553
BILE ESCULIN AZIDE AGAR
K
82
0552
EOSIN METHYLENE BLUE AGAR
K
81
2731
SEPTI-CHECK BLOOD CULTURE SLIDE
K
81
2187
SMITH'S SYSTEMIC FUNGAL MEDIUM
K
81
1648
ENDO AGAR
K
81
1644
HEKTOEN ENTERIC AGAR
K
81
1642
EOSIN METHYLENE BLUE AGAR (LEVINE)
K
81
1643
MACCONKEY AGAR
K
81
1647
SALMONELLA-SHIGELLA AGAR
K
81
1598
DNASE AGAR MEDIA
K
81
1611
MACCONKEY AGAR
K
81
1610
EOSIN METHYLENE BLUE AGAR (LEVINE)
K
81
1609
MANNITOL SALT AGAR
K
81
1605
HEKTOEN ENTERIC AGAR
K
81
1604
XYLOSE LYSINE DEOXYCHOLATE AGAR
K
81
1603
SALMONELLA SHIGELLA AGAR
K
81
1600
BILE ESCULIN MEDIA
K
81
1599
EOSIN METHYLENE BLUE AGAR
K
81
1514
BACILLUS CEREUS SELECTIVE(AGAR&SUPP)
K
81
1477
MACCONKEY AGAR
K
81
1478
EMB AGAR, LEVINE
K
81
1474
TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB
K
81
1422
STREP-ID PLATE
K
81
1420
MINERALS MODIFIED MED. BASE & SOD. GLUT.
K
81
1362
TCBS AGAR
K
81
1355
LYSINE IRON AGAR
K
81
1332
BRAIN HEART CC AGAR
K
81
1338
VIOLET RED BILE AGAR
K
81
1334
MYCOSEL
K
81
1331
SF BROTH
K
81
1327
SALMONELLA SHIGELLA AGAR
K
81
1324
PHENYLETHANOL AGAR
K
81
1131
HEKTOEN ENTERIC AGAR
K
81
1134
ACU-DESOXYCHOLATE AGAR
K
81
1133
EOSIN-METHYLENE BLUE AGAR
K
81
1129
LAURYL SULFATE BROTH
K
81
1041
BRILLIANT GREEN AGAR
K
81
1039
VOGEL & JOHNSON AGAR
K
81
1048
MACCONKEY AGAR
K
81
1046
STERILITY TEST BROTH
K
81
1045
LEVIN EOSIN-METHYLENE BLUE AGAR
K
81
1043
BISMUTH SULFITE AGAR
K
81
1042
XLD AGAR
K
81
1040
CETRIMEDE AGAR
K
81
1054
BIGGY AGAR
K
81
1038
BAIRD-PARKER AGAR
K
81
1037
MANNITAL SALT AGAR
K
81
0933
VOTEL-JOHNSON AGAR (MODIFIED)
K
81
0931
SS AGAR (MODIFIED)
K
81
0929
PERFRINGENS AGAR BASE
K
80
2947
ORICULT DTM
K
80
0980
HEXTOEN ENTERIC AGAR
K
80
0983
MACCONKEY AGAR
K
80
0745
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
K
80
0157
BISMUTH SULFITE AGAR
K
79
2424
CHOCOLATE TELLURITE AGAR
K
79
1942
BILE ESCULIN AZIDE AGAR
K
79
1940
UREA AGAR
K
79
1414
DTM (DERMATOPHYTE TEST MEDIUM) AGAR
K
79
1786
SALMONELLA SHIGELLA AGAR PLATE
K
79
1816
DC AGAR (DESOXYCHOLATE CITRATE AGAR)
K
79
1785
MEKTOEN ENTERIC AGAR 100X15MM PLATE
K
79
1787
XYLOSE LYSINE DESOXYCHOLATE AGAR PLATE
K
79
1627
MANNITOL SALT AGAR
K
79
1621
MANNITOL SALT AGAR
K
79
1555
LEVINE EOSIN METHYLER
K
79
1579
ANAEROBIC BRUCELLA BLOOD AGAR
K
79
1563
ANAEROBIC BRUCELLA LAKED BLOOD AGAR
K
79
1479
ENDO AGAR
K
79
1477
XLD AGAR (XYLASE LYSINE DESOXY AGAR)
K
79
1475
HEKTOEN ENTERIC AGAR
K
79
1518
BIGGY AGAR
K
79
1520
EMB AGAR (EOSIN METHYLENE BLUE AGAR)
K
79
1519
LEVINE EMB AGAR
K
79
1480
SS AGAR (SALMONELLA SHIGELLA AGAR)
K
79
1482
MACCONKEY MEDIA
K
79
1472
PHENYLETHANOL AGAG (PEA)
K
79
0624
LOMBARD-DOWELL BROTH MEDIUM W/LACTATE
K
79
0628
LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR
K
79
0469
STREP BLOOD AGAR-5% SHEEP BLOOD
K
79
0119
C/N SCREEN
K
78
0704
COLUMBIA AGAR WITH 5% RABBIT BLOOD
K
77
1647
JEMBEC-CVSB PLATE
JSJ
Culture Media, Selective And Non-Differential
JSK
Supplement, Culture Media
JSL
Culture Media, Anaerobic Transport
JSM
Culture Media, Non-Propagating Transport
JSN
Culture Media, Propagating Transport
JSP
Kit, Anaerobic Identification
JSR
Kit, Identification, Dermatophyte
JSS
Kit, Identification, Enterobacteriaceae
JST
Kit, Fastidious Organisms
JSW
Kit, Identification, Glucose Nonfermenter
JSX
Kit, Identification, Neisseria Gonorrhoeae
JSY
Kit, Identification, Mycobacteria
JSZ
Kit, Identification, Pseudomonas
JTA
Monitor, Microbial Growth
JTB
Device, Media Dispensing/Stacking
JTC
Device, Microtiter Diluting/Dispensing
JTL
Plasma, Coagulase, Human, Horse And Rabbit
JTM
Anaerobic Box Glove
JTO
Discs, Strips And Reagents, Microorganism Differentiation
JTQ
Bath, Incubators/Water, All
JTR
Kit, Quality Control For Culture Media
JTW
System, Transport, Aerobic
JTX
Transport Systems, Anaerobic
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
JWX
Kit, Screening, Staphylococcus Aureus
JWZ
Kit, Screening, Trichomonas
JXA
Kit, Screening, Urine
JXB
Kit, Identification, Yeast
JXC
Kit, Screening, Yeast
KZB
Automated Colony Counter
KZC
Manual Colony Counter
KZI
Culture Media, Enriched
KZJ
Device, Gas Generating
KZK
Reader, Zone, Automated
LGA
Device, Oxidase Test For Gonorrhea
LIB
Device, General Purpose, Microbiology, Diagnostic
LIO
Device, Specimen Collection
LJF
Device, Antimicrobial Drug Removal
LJG
Quality Control Slides
LKS
Device, Parasite Concentration
LLH
Reagents, Clostridium Difficile Toxin
LQL
Gram Positive Identification Panel
LQM
Gram Negative Identification Panel
LRH
Instrument For Auto Reader Of Overnight Microorganism Identification System
LSC
Neisseria Controls
LTS
Test Reagents, Neisseria Gonorrhoeae Biochemical
MCB
Antigen, C. Difficile
MDB
System, Blood Culturing
MJK
Dna Probe, Trichomonas Vaginalis
MJM
Dna Probe, Gardnerella Vaginalis
MLA
Dna Probe, Yeast
NZS
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
OMN
C. Difficile Nucleic Acid Amplification Test Assay
OUS
Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
PGX
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
PPU
Microbial Colony Image Assessment System
PQZ
Gbs Culture Media, Selective And Differential
QBD
Microbial Nucleic Acid Storage And Stabilization Device
QBQ
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
QMC
Transport Medium, Notified Per The Vtm Guidance
QQY
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-c—microbiology-devices
/
JSI
/
K791785
View Source
MEKTOEN ENTERIC AGAR 100X15MM PLATE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K791785
510(k) Type
Traditional
Applicant
AMERICAN LABORATORY SUPPLY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1979
Days to Decision
20 days