Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- GMBLight, Wood'S, Fluorescence1Product Code
- GTLPhages, Staphylococcal Typing, All Types1Product Code
- JRZMedia, Culture, Amino Acid Assay1Product Code
- JSACulture Media, Antibiotic Assay1Product Code
- JSBCulture Media, Vitamin Assay1Product Code
- JSCCulture Media, General Nutrient Broth1Product Code
- JSDCulture Media, Selective Broth1Product Code
- JSECulture Media, Multiple Biochemical Test1Product Code
- JSFCulture Media, Single Biochemical Test1Product Code
- JSGCulture Media, Non-Selective And Non-Differential1Product Code
- JSHCulture Media, Non-Selective And Differential1Product Code
- JSICulture Media, Selective And Differential1Product Code
- JSJCulture Media, Selective And Non-Differential1Product Code
- K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P34211Cleared 510(K)
- K881571YM BROTH1Cleared 510(K)
- K881565INHIBITORY MOLD AGAR1Cleared 510(K)
- K881578STREPTOSEL1Cleared 510(K)
- K881574W-L DIFFERENTIAL MEDIUM1Cleared 510(K)
- K881573PHYTONE YEAST EXTRACT AGAR1Cleared 510(K)
- K881561TERGITOL 7 BROTH1Cleared 510(K)
- K881570SABOURAUD MALTOSE AGAR1Cleared 510(K)
- K881530BRILLIANT GREEN AGAR W/SULFADIAZINE1Cleared 510(K)
- K881524DERMATOPHYTE TEST MEDIUM1Cleared 510(K)
- K881549MYCOLOGICAL AGAR W/LOW PH1Cleared 510(K)
- K881547MITIS SALIVARIUS AGAR1Cleared 510(K)
- K881544LITTMAN AGAR1Cleared 510(K)
- K881530BRILLIANT GREEN AGAR W/SULFADIAZINE1Cleared 510(K)
- K880123LOWENSTEIN-JENSEN SLANT1Cleared 510(K)
- K880124LOWENSTEIN-JENSEN, W/NACL1Cleared 510(K)
- K880945CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T35971Cleared 510(K)
- K880136CETRIMIDE SELECTIVE AGAR1Cleared 510(K)
- K880141BCYE, SELECTIVE (W/MPA)1Cleared 510(K)
- K880140BCYE AGAR1Cleared 510(K)
- K880128SABOURAUD DEXTROSE AGAR W/CHLORO1Cleared 510(K)
- K880137BHI WITH C & C SLANT1Cleared 510(K)
- K880716SLIDE CULTURE PLATE-POTATO FLAKE AGAR1Cleared 510(K)
- K880717SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR1Cleared 510(K)
- K874176BIOTIS (TM) HAEMOPHILUS DUCREYI1Cleared 510(K)
- K874178BIOTIS (TM) BCYE SELECTIVE1Cleared 510(K)
- K874345TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z30501Cleared 510(K)
- K874173BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI1Cleared 510(K)
- K874172BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)1Cleared 510(K)
- K873975PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P33231Cleared 510(K)
- K873951MICRO CULTURE MEDIA P3528, P3137, P3149, P31391Cleared 510(K)
- K873827MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)1Cleared 510(K)
- K873479COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z32061Cleared 510(K)
- K873412GRAM NEGATIVE (GN) BROTH, PRODUCT #T30381Cleared 510(K)
- K873327SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P33301Cleared 510(K)
- K873323SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T44121Cleared 510(K)
- K873326SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T30801Cleared 510(K)
- K873318SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL1Cleared 510(K)
- K873322SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T30881Cleared 510(K)
- K873319SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE1Cleared 510(K)
- K873216BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C1Cleared 510(K)
- K873224BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P37721Cleared 510(K)
- K873242BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM1Cleared 510(K)
- K873241BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM1Cleared 510(K)
- K873240BRAIN HEART INFUSION AGAR W/ C&C SLANT TUBE #T32851Cleared 510(K)
- K873239BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T44631Cleared 510(K)
- K873238BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T44501Cleared 510(K)
- K873237BRAIN HEART INFUS AGAR SLANT W/6% SB CHLORAMPHENIC1Cleared 510(K)
- K873234BRAIN HEART INFUSION AGAR W/C&C - PRODUCT #P34071Cleared 510(K)
- K873233BRAIN HEART INFUS AGAR W/5% SB & CHLORAMPHENICOL1Cleared 510(K)
- K873244BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP1Cleared 510(K)
- K873229BRAIN HEART INFUSION AGAR III - PRODUCT #P35901Cleared 510(K)
- K873231BRAIN HEART INFUSION AGAR W/GENTAMICIN - #P37041Cleared 510(K)
- K873230BRAIN HEART INFUSION AGAR IV - PRODUCT #P35911Cleared 510(K)
- K872690IAFP V. AGAR SELECTIVE1Cleared 510(K)
- K873056TRYPTIC SOY AGAR (TSA) W/SXT - PRODUCT #P29331Cleared 510(K)
- K872692IAFP P.E.A. AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K872673I.A.F.P. C.D.C. ANAEROBIC SHEEP BLOOD AGAR W/P.E.A1Cleared 510(K)
- K872674IAFP COLUMBIA C.N.A. WITH 5% SHEEP BLOOD1Cleared 510(K)
- K872676AFP MIDDLEBROOK 7H10 AGAR SLANT1Cleared 510(K)
- K872680IAFP HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K872684IAFP CAMPYLOBACTER BLASER1Cleared 510(K)
- K872689IAFP SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K872666IAFP K.V. ANAEROBIC AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K872665IAFP K.V. ANAEROBIC AGAR1Cleared 510(K)
- K872135MCBRIDE MEDIUM CM 8191Cleared 510(K)
- K871786GBNA MEDIUM1Cleared 510(K)
- K871702MRS AGAR AND MRS BROTH1Cleared 510(K)
- K871264CARIESCREEN LB1Cleared 510(K)
- K871357MCBRIDE AGAR, MODIFIED1Cleared 510(K)
- K870637DERMATOPHYTE TEST MEDIUM1Cleared 510(K)
- K870645MIDDLEBROOK 7H11 SELECTIVE AGAR1Cleared 510(K)
- K870647COLUMBIA CNA AGAR1Cleared 510(K)
- K870650NEOMYCIN ANAEROBIC BLOOD AGAR1Cleared 510(K)
- K870635REGAN-LOWE MEDIUM1Cleared 510(K)
- K871091BACTEROIDES BILE ESCULIN AGAR1Cleared 510(K)
- K871090ANAEROBIC PEA BLOOD AGAR1Cleared 510(K)
- K871093CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)1Cleared 510(K)
- K864251SELENITE F. BROTH1Cleared 510(K)
- K864250SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K870342P3700 COL. CNA W/5% SB1Cleared 510(K)
- K870134MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE1Cleared 510(K)
- K864755PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM1Cleared 510(K)
- K863820DRI-FORM: GBNA LISTERIA MEDIUM NO. M223001Cleared 510(K)
- K863526YEP (YEAST EXTRACT PHOSPHATE) AGAR1Cleared 510(K)
- K863524REGAN-LOWE CHARCOAL AGAR1Cleared 510(K)
- K863191BACTEC 13A MEDIUM (7H13)1Cleared 510(K)
- K863289CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN1Cleared 510(K)
- K862400BIOTIS KV LAKED BLOOD AGAR1Cleared 510(K)
- K862399BIOTIS SXT AGAR1Cleared 510(K)
- K861734REGAN-LOWE AGAR1Cleared 510(K)
- K860862CAMPYLOBACTER CVA AGAR1Cleared 510(K)
- K860861MCBRIDE LISTERIA AGAR1Cleared 510(K)
- K860405BIOTIS TSB WITH 6.5% NACL1Cleared 510(K)
- K860383BIOTIS CLOSTRIDIUM DIFFICILE AGAR1Cleared 510(K)
- K860390BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN1Cleared 510(K)
- K860391BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT1Cleared 510(K)
- K860394BIOTIS CETRIMIDE AGAR1Cleared 510(K)
- K860395BIOTIS HAEMPHILLUS ISOLATION AGAR1Cleared 510(K)
- K860398BIOTIS POTATO DEXTROSE AGAR1Cleared 510(K)
- K860404BIOTIS MIDDLEBROOK 7H10 AGAR SLANT1Cleared 510(K)
- K860406BIOTIS MIDDLEBROOK 7H9 BROTH1Cleared 510(K)
- K860407BIOTIS ANAEROBIC CNA1Cleared 510(K)
- K860416BIOTIS REGAN-LOWE1Cleared 510(K)
- K854457COLUMBIA CNA AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K854453P.E.Z. AGAR (PHENYLETHANOL AGAR)1Cleared 510(K)
- K854456CAMPYLOBACTER BLOOD AGAR1Cleared 510(K)
- K853335BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN1Cleared 510(K)
- K853230APL MYCOBIOTIC AGAR1Cleared 510(K)
- K853231APL SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K853227APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)1Cleared 510(K)
- K852987CARIESCREEN - SM1Cleared 510(K)
- K851238CHAMBER V-9 PLUS AGAR1Cleared 510(K)
- K851593SELECTIVE STREPTOCOCCUS AGAR1Cleared 510(K)
- K851591PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD1Cleared 510(K)
- K851592SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K851599TRICHOMONAS BROTH (KUPFORBERG1Cleared 510(K)
- K851580COLUMBIZ CNA AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K851582GN BROTH1Cleared 510(K)
- K851590MYCOLOGY AGAR W/ANTIBOTICS1Cleared 510(K)
- K850765STREP-KIT1Cleared 510(K)
- K851249SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC1Cleared 510(K)
- K851347KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR1Cleared 510(K)
- K851348COBA AGAR1Cleared 510(K)
- K850555CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI1Cleared 510(K)
- K850969INHIBITORY MOLD AGAR PLATE1Cleared 510(K)
- K850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA1Cleared 510(K)
- K850832CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ1Cleared 510(K)
- K850716SELENITE F BROTH1Cleared 510(K)
- K850846SALT BROTH1Cleared 510(K)
- K850556CDC ANEROBIC BLOOD AGAR W/PEA, ANEROBIC PEA1Cleared 510(K)
- K850554LKV AGAR, LKV ANAEROBIC AGAR1Cleared 510(K)
- K850557SELECTIVE STREP AGAR1Cleared 510(K)
- K844932MALT AGAR1Cleared 510(K)
- K844929INHIBITORY MOLD AGAR1Cleared 510(K)
- K844931MYCOLOGICAL AGAR W/ANTIBIOTICS1Cleared 510(K)
- K844525SELENITE CYSTINE BROTH1Cleared 510(K)
- K844524GN BROTH1Cleared 510(K)
- K844534CAMPYLOBACTER CVA AGAR1Cleared 510(K)
- K844533TRICHOMONAS BROTH1Cleared 510(K)
- K844530BRAIN HEART INFUSION W/6.5% SODIUM CHLORIDE1Cleared 510(K)
- K844527SELENITE BROTH1Cleared 510(K)
- K844523CAMPYLOBACTER THIOGLYCOLLATE MEDIUM1Cleared 510(K)
- K844518STREPTOCOCCUS SELECTIVE AGAR1Cleared 510(K)
- K844517COLUMBIA CNA AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K843653CAMPYLOCACTER SUPPLEMENT1Cleared 510(K)
- K834424SFP AGAR PLATES1Cleared 510(K)
- K834422PHENYLETHYL ALCOHOL AGAR PLATE1Cleared 510(K)
- K834419COLUMBIA CNA AGAR PLATE1Cleared 510(K)
- K843766BIOTIS MYCOLOGICAL MEDIA & SLANT1Cleared 510(K)
- K843765BIOTIS MYCOBIOTIC AGAR1Cleared 510(K)
- K841746SALMONELLA-SHIGELLA AGAR1Cleared 510(K)
- K841845SELECTIVE CULTURE MED. COLUMBIA CNA1Cleared 510(K)
- K841839SELECTIVE CULTURE MED. SELECTIVE STREP1Cleared 510(K)
- K841840SELECTIVE CULTURE MED. PHENYLETHYL ALCO1Cleared 510(K)
- K841673HAEMOPHILUS ISOLATION AGAR 28271Cleared 510(K)
- K841658KF STREPTOCOCCUS AGAR1Cleared 510(K)
- K840332CAMPYLOBACTER AGAR BASE1Cleared 510(K)
- K841754COLUMBIA CNA AGAR1Cleared 510(K)
- K841210SELECTIVE & NON-DIFFERENTIAL1Cleared 510(K)
- K841135MYCOSEL AGAR W/CHLORAMPHENICOL &1Cleared 510(K)
- K841140PHENYLETHYL ALCOHOL BLOOD AGAR1Cleared 510(K)
- K841139COLUMBIA AGAR W/COLISTIN, NALADIXIC1Cleared 510(K)
- K841136SABOURAUD DEXTROSE AGAR W/CHLORAMPHE1Cleared 510(K)
- K841133THAYER MARTIN MEDIUM1Cleared 510(K)
- K840890BUFFERED CYE AGAR DEEP W/SUPPLEMENTS1Cleared 510(K)
- K840554BLOOD AGAR W/AMPICILLIN1Cleared 510(K)
- K840520MYCOLOGICAL SELECTIVE MEDIUM1Cleared 510(K)
- K840519DTM AGAR1Cleared 510(K)
- K840076GN BROTH TUBE1Cleared 510(K)
- K840074KV BLOOD AGAR PLATE1Cleared 510(K)
- K840078SABOURAUD DEXTROSE AGAR TUBE1Cleared 510(K)
- K833966PUMP INFUSION WEARABLE INFUSION PUMP1Cleared 510(K)
- K834417CAMPY BRUCELLA AGAR PLATE1Cleared 510(K)
- K834317SELENITE BROTH1Cleared 510(K)
- K834313CAMPY 31Cleared 510(K)
- K834314CAMPY 51Cleared 510(K)
- K834325INHIBITORY MOLD AGAR1Cleared 510(K)
- K834318BRUCELLA W/H & K1Cleared 510(K)
- K834020PEPTIC DIGEST AGAR1Cleared 510(K)
- K834326CAMPY 5H1Cleared 510(K)
- K833967CVA1Cleared 510(K)
- K834068CEB1Cleared 510(K)
- K834010DERMATOPHYTE TEST MEDIUM1Cleared 510(K)
- K834005SELECTIVE STREPTOCOCCUS AGAR1Cleared 510(K)
- K834008SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K834017CHOCOLATE AGAR W/CHEMICALLY DEFINED1Cleared 510(K)
- K834018CAMPY MEDIUM1Cleared 510(K)
- K833760CLOSTRIDIUM DIFFICILE EY AGAR P27871Cleared 510(K)
- K833886BRUCELLA AGAR1Cleared 510(K)
- K833887BRUCELLA BROTH1Cleared 510(K)
- K833220LOWENSTEIN-JENSEN MEDIUM BASE1Cleared 510(K)
- K833136CLOSTRIDIUM DIFFICILE1Cleared 510(K)
- K833010CIN AGAR YERSINIA-SELECTIVE AGAR1Cleared 510(K)
- K832536BRILLIANT GREEN AGAR PLATE1Cleared 510(K)
- K832861SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K832860SXT BLOOD AGAR1Cleared 510(K)
- K832588CIN AGAR1Cleared 510(K)
- K832583SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K832582MYCOSEL AGAR1Cleared 510(K)
- K832581DTM-DERMATOPHYTE TEST MEDIUM1Cleared 510(K)
- K832613MANNITOL SALT AGAR1Cleared 510(K)
- K832614SELENITE BROTH1Cleared 510(K)
- K832615SF BROTH1Cleared 510(K)
- K831279CLOSTRIDIUM DIFFICLE MEDIA1Cleared 510(K)
- K831220CLOSTRIDIUM DIFFICILE MEDIA1Cleared 510(K)
- K823885SELECTIVE LEGIONELLA MEDIA1Cleared 510(K)
- K830384LEGIONELLA SELECTIVE SUPPLEMENTS1Cleared 510(K)
- K830080BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K830069MYCOBIOTIC AGAR1Cleared 510(K)
- K830081BILE ESCULIN AGAR1Cleared 510(K)
- K830076CAMPYLOCACTER SELECTIVE AGAR BLASER'S1Cleared 510(K)
- K830067PHENYLETHANOL AGAR W/50% SHEEP BLOOD1Cleared 510(K)
- K830066SABOURAND DEXTROSE AGAR1Cleared 510(K)
- K823308MYCAREL AGAR MYCOBROTIC AGAR1Cleared 510(K)
- K823248SCHAEDLER AGARS1Cleared 510(K)
- K823139SMITH'S MEDIUM1Cleared 510(K)
- K823102AGAR P1Cleared 510(K)
- K823050CIN AGAR MEDIUM1Cleared 510(K)
- K822994CORN MEAL AGAR W/POLYSORBATE 801Cleared 510(K)
- K822527ANAEROBE PEA PLATE1Cleared 510(K)
- K822664PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP1Cleared 510(K)
- K822660VOGEL JOHNSON AGAR1Cleared 510(K)
- K822659YERSINIA AGAR BASE & SUPPLEMENT1Cleared 510(K)
- K822559SXT BLOOD AGAR1Cleared 510(K)
- K8215966.5% NACL BROTH1Cleared 510(K)
- K821603MYCOBIOTIC AGAR1Cleared 510(K)
- K821599GRAM NEGATIVE BROTH1Cleared 510(K)
- K821493LITTMAN OXGAL AGAR1Cleared 510(K)
- K821218CAMPY-S AGAR1Cleared 510(K)
- K820863MEDIA FOR IN-VITRO DIAGNOSTIC USE1Cleared 510(K)
- K820845DULTURE MEDIA, SELECTIVE & NON-DIFFER1Cleared 510(K)
- K820806#2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL1Cleared 510(K)
- K820799#2002 MANNITOL SALT AGAR1Cleared 510(K)
- K820803#2003 MYCOBIOTIC AGAR1Cleared 510(K)
- K820804#2013 CNA 5% SHEEP BLOOD1Cleared 510(K)
- K820805#2005 SABOURAUD DEXTROSE AGAR/#4002 SLA1Cleared 510(K)
- K820807#2011 STREP SELECTIVE AGAR1Cleared 510(K)
- K820560PHENYLETHANOL AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K820561SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K820562CAMPYLOBACTER SELECTIVE MEDIUM1Cleared 510(K)
- K820550POTATO DEXTROSE AGAR1Cleared 510(K)
- K820557DERMATHPHYTE TEST MEDIUM1Cleared 510(K)
- K820555ANAEROBE BLOOD AGAR W/KANAMYCIN & VANCO1Cleared 510(K)
- K820554COLUMBIZ CNA AGAR W/15% SHEEP BLOOD1Cleared 510(K)
- K820295CIN AGAR BASE1Cleared 510(K)
- K820060CAMPYLOBACTER THIOGLYCOLLATE MED W/51Cleared 510(K)
- K812796ANAEROBIC CNA BLOOD AGAR1Cleared 510(K)
- K811733AZIDE BLOOD AGAR BASE1Cleared 510(K)
- K811736DCLS AGAR1Cleared 510(K)
- K811650MACCONKEY BROTH1Cleared 510(K)
- K811601PHENYETHYL ALCOHOL AGAR1Cleared 510(K)
- K811607COLUMBIA AGAR CNA W/5% SHEEP BLOOD1Cleared 510(K)
- K811354GN BROTH (HAJNA)1Cleared 510(K)
- K811356TRYPTONE AZOLECITHIN TWEEN1Cleared 510(K)
- K811333EC MEDIUM1Cleared 510(K)
- K811337TERGITOL 7 AGAR1Cleared 510(K)
- K811339TODD HEWITT BROTH1Cleared 510(K)
- K811329SCHAEDLER BROTH1Cleared 510(K)
- K811336M-GREEN YEAST & MOLD BROTH1Cleared 510(K)
- K811322POTATO DEXTROSE AGAR1Cleared 510(K)
- K811328SCHAEDLER AGAR1Cleared 510(K)
- K811325SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K811137COLUMBIA CNA AGAR1Cleared 510(K)
- K811128BRUCELLA AGAR1Cleared 510(K)
- K810961CAMPYLOBACTER MED. (PLATE)1Cleared 510(K)
- K811057BRILLIANT GREEN BILE BROTH 2%1Cleared 510(K)
- K810181DERMOTOPHYTE TEST MEDIUM1Cleared 510(K)
- K802757BUFFERED CHARCOAL YEAST EXTRACT AGAR1Cleared 510(K)
- K802758SELECTIVE CHARCOAL YEAST EXTRACT AGAR1Cleared 510(K)
- K803027CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.1Cleared 510(K)
- K803024CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.1Cleared 510(K)
- K803022CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.1Cleared 510(K)
- K802946MYCOLOGY CULTURE SYSTEM1Cleared 510(K)
- K802495CLOSTRIDIUM DIFFICILE AGAR BASE1Cleared 510(K)
- K802571CYE BIPHASIC BLOOD CULTURE MEDIUM1Cleared 510(K)
- K800754NICKERSON'S MED. SELECTIVE CULTURE MEDIU1Cleared 510(K)
- K800807CORN MEAL AGAR MEDIA1Cleared 510(K)
- K800541CAMPYLOBACTER AGAR W/5-ANTIMICROBICS1Cleared 510(K)
- K792715SMITH'S SYSTEMIC FUNGAL MEDIUM1Cleared 510(K)
- K792675CHARCOAL YEAST EXTRACT(CYE) AGAR1Cleared 510(K)
- K800329CAMPYLOBACTER AGAR, CAT. NO. P25361Cleared 510(K)
- K800158AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD1Cleared 510(K)
- K800156STAPHYLOCOCCUS MED. 1101Cleared 510(K)
- K792674CAMPY BLOOD AGAR1Cleared 510(K)
- K792676CAMPY THIO1Cleared 510(K)
- K792720TRYPTIC SOY SXT AGAR W/SHEEP BLOOD1Cleared 510(K)
- K792595SF MEDIUM (SF BROTH, STREPTOCOCCUS1Cleared 510(K)
- K792596TRYPTIC SOY AGAR W/PHENYLETHANOL &1Cleared 510(K)
- K792593PHENYLETHANOL AGAR1Cleared 510(K)
- K792422TETRATHIONATE BROTH BASE1Cleared 510(K)
- K792287KF STREPTOCOCCUS AGAR1Cleared 510(K)
- K791697CDC ANAEROBIC BLOOD AGAR PHENETHYLAL1Cleared 510(K)
- K791670SABOURAUD AGAR MODIFIED1Cleared 510(K)
- K791626MYCOBIOTIC AGAR1Cleared 510(K)
- K791629BRAIN HEART CC AGAR1Cleared 510(K)
- K791578CAMPYLOBACTER SELECTIVE MEDIUM1Cleared 510(K)
- K791595BAIRD-PARKER AGAR1Cleared 510(K)
- K791593BRILLIANT GREEN AGAR1Cleared 510(K)
- K791592BRILLIANT GREEN BILE 2%1Cleared 510(K)
- K781602CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM.1Cleared 510(K)
- K781603CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH.1Cleared 510(K)
- K771661MIDDLEBROOK 7H11 AGAR (PLATE)1Cleared 510(K)
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- K760457SCHAEDLER-SELECTIVE AGAR CNA1Cleared 510(K)
- K760460SCHAEDLER SELECTIVE AGAR-KV1Cleared 510(K)
- JSKSupplement, Culture Media1Product Code
- JSLCulture Media, Anaerobic Transport1Product Code
- JSMCulture Media, Non-Propagating Transport1Product Code
- JSNCulture Media, Propagating Transport1Product Code
- JSPKit, Anaerobic Identification1Product Code
- JSRKit, Identification, Dermatophyte1Product Code
- JSSKit, Identification, Enterobacteriaceae1Product Code
- JSTKit, Fastidious Organisms1Product Code
- JSWKit, Identification, Glucose Nonfermenter1Product Code
- JSXKit, Identification, Neisseria Gonorrhoeae1Product Code
- JSYKit, Identification, Mycobacteria1Product Code
- JSZKit, Identification, Pseudomonas1Product Code
- JTAMonitor, Microbial Growth1Product Code
- JTBDevice, Media Dispensing/Stacking1Product Code
- JTCDevice, Microtiter Diluting/Dispensing1Product Code
- JTLPlasma, Coagulase, Human, Horse And Rabbit1Product Code
- JTMAnaerobic Box Glove1Product Code
- JTODiscs, Strips And Reagents, Microorganism Differentiation1Product Code
- JTQBath, Incubators/Water, All1Product Code
- JTRKit, Quality Control For Culture Media1Product Code
- JTWSystem, Transport, Aerobic1Product Code
- JTXTransport Systems, Anaerobic1Product Code
- JTYCulture Media, For Isolation Of Pathogenic Neisseria2Product Code
- JWXKit, Screening, Staphylococcus Aureus1Product Code
- JWZKit, Screening, Trichomonas1Product Code
- JXAKit, Screening, Urine1Product Code
- JXBKit, Identification, Yeast1Product Code
- JXCKit, Screening, Yeast1Product Code
- KZBAutomated Colony Counter1Product Code
- KZCManual Colony Counter1Product Code
- KZICulture Media, Enriched1Product Code
- KZJDevice, Gas Generating1Product Code
- KZKReader, Zone, Automated1Product Code
- LGADevice, Oxidase Test For Gonorrhea3Product Code
- LIBDevice, General Purpose, Microbiology, Diagnostic1Product Code
- LIODevice, Specimen Collection1Product Code
- LJFDevice, Antimicrobial Drug Removal1Product Code
- LJGQuality Control Slides1Product Code
- LKSDevice, Parasite Concentration1Product Code
- LLHReagents, Clostridium Difficile Toxin1Product Code
- LQLGram Positive Identification Panel1Product Code
- LQMGram Negative Identification Panel1Product Code
- LRHInstrument For Auto Reader Of Overnight Microorganism Identification System1Product Code
- LSCNeisseria Controls1Product Code
- LTSTest Reagents, Neisseria Gonorrhoeae Biochemical1Product Code
- MCBAntigen, C. Difficile1Product Code
- MDBSystem, Blood Culturing1Product Code
- MJKDna Probe, Trichomonas Vaginalis1Product Code
- MJMDna Probe, Gardnerella Vaginalis1Product Code
- MLADna Probe, Yeast1Product Code
- NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast1Product Code
- OMNC. Difficile Nucleic Acid Amplification Test Assay1Product Code
- OUSMethicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt1Product Code
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System2Product Code
- PPUMicrobial Colony Image Assessment System2Product Code
- PQZGbs Culture Media, Selective And Differential1Product Code
- QBDMicrobial Nucleic Acid Storage And Stabilization Device2Product Code
- QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture1Product Code
- QMCTransport Medium, Notified Per The Vtm Guidance1Product Code
- QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms2Product Code
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIOTIS (TM) HAEMOPHILUS DUCREYI
- Page Type
- Cleared 510(K)
- 510(k) Number
- K874176
- 510(k) Type
- Traditional
- Applicant
- OTISVILLE BIOPHARM, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/5/1988
- Days to Decision
- 115 days