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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
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Miscellaneous
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
K
88
0946
NUTRIENT GELATIN - PRODUCT NUMBER T2860
1
Cleared 510(K)
K
88
0119
MOELLERS DECARBOXYLASE, ONITHINE
1
Cleared 510(K)
K
88
0126
LAURYL TRYPTOSE BROTH
1
Cleared 510(K)
K
88
0120
MOELLERS DECARBOXYLASE, LYSINE
1
Cleared 510(K)
K
88
0139
ONPG TEST REAGENT
1
Cleared 510(K)
K
88
0106
ACETAMIDE AGAR SLANT
1
Cleared 510(K)
K
88
0110
CYSTINE TRYPTIC MEDIUM W/DEXTROSE
1
Cleared 510(K)
K
88
0135
NITRATE BROTH
1
Cleared 510(K)
K
88
0111
CYSTINE TRYPTIC MEDIUM W/SUCROSE
1
Cleared 510(K)
K
88
0112
CYSTINE TRYPTIC MEDIUM W/ MALTOSE
1
Cleared 510(K)
K
88
0118
MOELLOERS DECARBOXYLASE, ARGININE
1
Cleared 510(K)
K
88
0139
ONPG TEST REAGENT
1
Cleared 510(K)
K
88
0135
NITRATE BROTH
1
Cleared 510(K)
K
88
0115
NUTRIENT GELATIN
1
Cleared 510(K)
K
87
4174
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
1
Cleared 510(K)
K
87
4175
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
1
Cleared 510(K)
K
87
3828
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
1
Cleared 510(K)
K
87
2691
IAFP UREA AGAR SLANT
1
Cleared 510(K)
K
87
0641
TRYPTONE BROTH, 2%
1
Cleared 510(K)
K
86
4241
DNASE AGAR
1
Cleared 510(K)
K
86
4256
TRYPTONE WATER (1%)
1
Cleared 510(K)
K
86
2398
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
1
Cleared 510(K)
K
86
2397
BIOTIS DECARBOXYLASE MEDIA, LYSINE
1
Cleared 510(K)
K
86
2396
BIOTIS DECARBOXYLASE MEDIA, ARGININE
1
Cleared 510(K)
K
86
2392
BIOTIS MOTILITY TEST MEDIUM
1
Cleared 510(K)
K
85
0194
CAFFEIC ACID DISK
1
Cleared 510(K)
K
85
0545
ACETATE DIFFERENTIAL AGAR
1
Cleared 510(K)
K
85
0550
SIMMONS CITRATE AGAR
1
Cleared 510(K)
K
84
4544
CYSTINE TRYPTIC AGAR W/MALTOSE
1
Cleared 510(K)
K
84
4546
CYSTINE TRYPTIC AGAR W/SUCROSE
1
Cleared 510(K)
K
84
4545
CYSTINE TRYPTIC AGAR W/MANNITOL
1
Cleared 510(K)
K
84
4542
CYSTINE TRYPTIC AGAR W/DEXTROSE
1
Cleared 510(K)
K
84
4543
CYSTINE TRYPTIC AGAR W/LACTOSE
1
Cleared 510(K)
K
84
4539
PHENOL RED BROTH W/CARBOHYDRATES
1
Cleared 510(K)
K
84
4540
CYSTINE TRYPTIC AGAR W/FRUCTOSE
1
Cleared 510(K)
K
84
3364
DIFFERENTIATION DISKS BILE ESCULIN
1
Cleared 510(K)
K
84
2871
HIPPURATE TEST REAGENT
1
Cleared 510(K)
K
84
2869
DECARBOXYLASE TEST REAGENT
1
Cleared 510(K)
K
84
2872
INDOLE REAGENT
1
Cleared 510(K)
K
84
2870
VOGES-PROSKAUER REAGENT A
1
Cleared 510(K)
K
84
2867
VOGES-PROSKAUER REAGENT B
1
Cleared 510(K)
K
84
2868
HIPPURATE TEST DISKS
1
Cleared 510(K)
K
84
2853
LYSINE IRON AGAR
1
Cleared 510(K)
K
84
2855
CHRISTENSEN'S UREA AGAR
1
Cleared 510(K)
K
84
2600
STREP-A-CHEK
1
Cleared 510(K)
K
84
2299
ZINC DUST SUSPENSION
1
Cleared 510(K)
K
84
2298
OXIDASE TEST STRIPS-OXIDASESURE
1
Cleared 510(K)
K
84
2291
SPOT TEST CATALASE TEST
1
Cleared 510(K)
K
84
2290
SPOT TEST NINHYDRIN REAGENTS
1
Cleared 510(K)
K
84
2300
ONPG DISKS
1
Cleared 510(K)
K
84
2297
ARGINIE BROTH
1
Cleared 510(K)
K
84
2098
RIM H2S
1
Cleared 510(K)
K
84
2097
RIM SPOT INDOLE
1
Cleared 510(K)
K
84
2072
L-ALANINE-4-NITROANILIDE
1
Cleared 510(K)
K
84
1659
DRIGALSKI LITMUS LACTOSE AGAR
1
Cleared 510(K)
K
84
1389
RIM-DNASE KIT
1
Cleared 510(K)
K
84
0685
PORPHYRIN TEST AGAR
1
Cleared 510(K)
K
84
1212
SINGLE BIOCHEMICAL TEST
1
Cleared 510(K)
K
83
4327
CIN AGAR
1
Cleared 510(K)
K
83
0397
PEM-C
1
Cleared 510(K)
K
82
2995
ANDRADES FERMENTATION MEDIA
1
Cleared 510(K)
K
82
2996
JORDANS TARTRATE AGAR
1
Cleared 510(K)
K
82
2999
DNASE TEST AGAR W/TOLUIDINE BLUE
1
Cleared 510(K)
K
82
3000
MACATE BROTH
1
Cleared 510(K)
K
82
3001
PEPTONE IRON AGAR
1
Cleared 510(K)
K
82
2694
YEAST ASSIMILATION BROTH
1
Cleared 510(K)
K
82
1845
EGG YOLK AGAR (PLATE)
1
Cleared 510(K)
K
82
1593
BILE ESCULIN AZIDE BROTH
1
Cleared 510(K)
K
82
1594
UREA AGAR SLANT
1
Cleared 510(K)
K
82
1606
BILE ESCULIN AGAR
1
Cleared 510(K)
K
82
0839
CULTURE MEDIA, SINGLE BIOCHEM. TEST
1
Cleared 510(K)
K
82
0809
#2008 SIMMONS CITRATE
1
Cleared 510(K)
K
82
0149
PYR BROTH
1
Cleared 510(K)
K
81
2468
PYRR MICROTUBE
1
Cleared 510(K)
K
81
2470
HIPP MICROTUBE
1
Cleared 510(K)
K
81
2469
RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB
1
Cleared 510(K)
K
81
2465
PHOS MICROTUBES
1
Cleared 510(K)
K
80
0287
CEPH LACTAM DISK
1
Cleared 510(K)
K
79
1945
NITRATE BROTH
1
Cleared 510(K)
K
79
1476
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
1
Cleared 510(K)
K
79
1474
SIMMONS CITRATE AGAR
1
Cleared 510(K)
K
79
0626
LOMBARD-DOWELL GLUCOSE AGAR
1
Cleared 510(K)
K
79
0231
DECARBOXYLASE, BUFFERED LYSINE
1
Cleared 510(K)
K
78
1506
MIC-BIO-PLATE
1
Cleared 510(K)
K
78
1369
MICRODILUTION ANAEROBE ID. PANEL
1
Cleared 510(K)
K
78
0907
MIC-2000
1
Cleared 510(K)
K
78
0533
PRE-REDUCED MEDIA
1
Cleared 510(K)
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
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 25 January 2026 at 3:41 am
MI
/
subpart-c—microbiology-devices
/
JSF
/
K872691
View Source
IAFP UREA AGAR SLANT
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K872691
510(k) Type
Traditional
Applicant
I.A.F. PRODUCTION, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
8/11/1987
Days to Decision
35 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
K
88
0946
NUTRIENT GELATIN - PRODUCT NUMBER T2860
K
88
0119
MOELLERS DECARBOXYLASE, ONITHINE
K
88
0126
LAURYL TRYPTOSE BROTH
K
88
0120
MOELLERS DECARBOXYLASE, LYSINE
K
88
0139
ONPG TEST REAGENT
K
88
0106
ACETAMIDE AGAR SLANT
K
88
0110
CYSTINE TRYPTIC MEDIUM W/DEXTROSE
K
88
0135
NITRATE BROTH
K
88
0111
CYSTINE TRYPTIC MEDIUM W/SUCROSE
K
88
0112
CYSTINE TRYPTIC MEDIUM W/ MALTOSE
K
88
0118
MOELLOERS DECARBOXYLASE, ARGININE
K
88
0139
ONPG TEST REAGENT
K
88
0135
NITRATE BROTH
K
88
0115
NUTRIENT GELATIN
K
87
4174
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
K
87
4175
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
K
87
3828
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
K
87
2691
IAFP UREA AGAR SLANT
K
87
0641
TRYPTONE BROTH, 2%
K
86
4241
DNASE AGAR
K
86
4256
TRYPTONE WATER (1%)
K
86
2398
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
K
86
2397
BIOTIS DECARBOXYLASE MEDIA, LYSINE
K
86
2396
BIOTIS DECARBOXYLASE MEDIA, ARGININE
K
86
2392
BIOTIS MOTILITY TEST MEDIUM
K
85
0194
CAFFEIC ACID DISK
K
85
0545
ACETATE DIFFERENTIAL AGAR
K
85
0550
SIMMONS CITRATE AGAR
K
84
4544
CYSTINE TRYPTIC AGAR W/MALTOSE
K
84
4546
CYSTINE TRYPTIC AGAR W/SUCROSE
K
84
4545
CYSTINE TRYPTIC AGAR W/MANNITOL
K
84
4542
CYSTINE TRYPTIC AGAR W/DEXTROSE
K
84
4543
CYSTINE TRYPTIC AGAR W/LACTOSE
K
84
4539
PHENOL RED BROTH W/CARBOHYDRATES
K
84
4540
CYSTINE TRYPTIC AGAR W/FRUCTOSE
K
84
3364
DIFFERENTIATION DISKS BILE ESCULIN
K
84
2871
HIPPURATE TEST REAGENT
K
84
2869
DECARBOXYLASE TEST REAGENT
K
84
2872
INDOLE REAGENT
K
84
2870
VOGES-PROSKAUER REAGENT A
K
84
2867
VOGES-PROSKAUER REAGENT B
K
84
2868
HIPPURATE TEST DISKS
K
84
2853
LYSINE IRON AGAR
K
84
2855
CHRISTENSEN'S UREA AGAR
K
84
2600
STREP-A-CHEK
K
84
2299
ZINC DUST SUSPENSION
K
84
2298
OXIDASE TEST STRIPS-OXIDASESURE
K
84
2291
SPOT TEST CATALASE TEST
K
84
2290
SPOT TEST NINHYDRIN REAGENTS
K
84
2300
ONPG DISKS
K
84
2297
ARGINIE BROTH
K
84
2098
RIM H2S
K
84
2097
RIM SPOT INDOLE
K
84
2072
L-ALANINE-4-NITROANILIDE
K
84
1659
DRIGALSKI LITMUS LACTOSE AGAR
K
84
1389
RIM-DNASE KIT
K
84
0685
PORPHYRIN TEST AGAR
K
84
1212
SINGLE BIOCHEMICAL TEST
K
83
4327
CIN AGAR
K
83
0397
PEM-C
K
82
2995
ANDRADES FERMENTATION MEDIA
K
82
2996
JORDANS TARTRATE AGAR
K
82
2999
DNASE TEST AGAR W/TOLUIDINE BLUE
K
82
3000
MACATE BROTH
K
82
3001
PEPTONE IRON AGAR
K
82
2694
YEAST ASSIMILATION BROTH
K
82
1845
EGG YOLK AGAR (PLATE)
K
82
1593
BILE ESCULIN AZIDE BROTH
K
82
1594
UREA AGAR SLANT
K
82
1606
BILE ESCULIN AGAR
K
82
0839
CULTURE MEDIA, SINGLE BIOCHEM. TEST
K
82
0809
#2008 SIMMONS CITRATE
K
82
0149
PYR BROTH
K
81
2468
PYRR MICROTUBE
K
81
2470
HIPP MICROTUBE
K
81
2469
RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB
K
81
2465
PHOS MICROTUBES
K
80
0287
CEPH LACTAM DISK
K
79
1945
NITRATE BROTH
K
79
1476
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
K
79
1474
SIMMONS CITRATE AGAR
K
79
0626
LOMBARD-DOWELL GLUCOSE AGAR
K
79
0231
DECARBOXYLASE, BUFFERED LYSINE
K
78
1506
MIC-BIO-PLATE
K
78
1369
MICRODILUTION ANAEROBE ID. PANEL
K
78
0907
MIC-2000
K
78
0533
PRE-REDUCED MEDIA
JSG
Culture Media, Non-Selective And Non-Differential
JSH
Culture Media, Non-Selective And Differential
JSI
Culture Media, Selective And Differential
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
/
JSF
/
K872691
View Source
IAFP UREA AGAR SLANT
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K872691
510(k) Type
Traditional
Applicant
I.A.F. PRODUCTION, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
8/11/1987
Days to Decision
35 days