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Innolitics
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Cardiovascular
Review Panel
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Review Panel
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Hematology
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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
K
96
2265
MLX MICROTITER PLATE LUMINOMETER
1
Cleared 510(K)
K
88
3995
X-ACT UREA/TDA
1
Cleared 510(K)
K
88
3996
X-ACT LDC/IND
1
Cleared 510(K)
K
88
0133
MIL MEDIUM
1
Cleared 510(K)
K
88
0116
MRVP BROTH
1
Cleared 510(K)
K
87
4537
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
1
Cleared 510(K)
K
87
1096
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
1
Cleared 510(K)
K
86
4674
MICRODILUTION IDENTIFICATION PANELS
1
Cleared 510(K)
K
86
2393
BIOTIS LITMUS MILK
1
Cleared 510(K)
K
86
0415
BIOTIS SIMMON CITRATE AGAR
1
Cleared 510(K)
K
86
0413
BIOTIS TSI
1
Cleared 510(K)
K
86
0414
BIOTIS ORNITHINE INDOLE MOTILITY MEDIA
1
Cleared 510(K)
K
86
0415
BIOTIS SIMMON CITRATE AGAR
1
Cleared 510(K)
K
86
0194
AUSTIN ENTERIC SYSTEM
1
Cleared 510(K)
K
85
0982
CTAPI - NEISSERA SCREEN
1
Cleared 510(K)
K
85
0734
DIFFERENTIAL CULTURE MEDIUM
1
Cleared 510(K)
K
85
0546
KLIGLER IRON AGAR KIA
1
Cleared 510(K)
K
85
0551
SIM MEDIUM
1
Cleared 510(K)
K
85
0548
LYSINE IRON AGAR LIA
1
Cleared 510(K)
K
85
0547
MOTILITY INDOLE ORNITHINE AGAR
1
Cleared 510(K)
K
84
3768
BIOTIS KLIGLER IRON AGAR
1
Cleared 510(K)
K
84
2451
RIM STREP KIT
1
Cleared 510(K)
K
84
2424
BIOTIS LD-PRESUMPTO QUADRANT PLATE
1
Cleared 510(K)
K
84
1204
MULTIPLE BIOCHEMICAL TEST
1
Cleared 510(K)
K
83
4002
LYSINE IRON AGAR
1
Cleared 510(K)
K
83
4012
SIM MEDIUM
1
Cleared 510(K)
K
83
4004
MYCOBIOTIC AGAR
1
Cleared 510(K)
K
83
4003
MOTILITY INDOLE ORNITHINE-MEDIUM
1
Cleared 510(K)
K
83
4001
KLIGLER IRON AGAR
1
Cleared 510(K)
K
83
2568
INDOLE NITRATE MEDIUM
1
Cleared 510(K)
K
83
0525
API 20GP
1
Cleared 510(K)
K
82
2998
CHRISTENSENS CITRATE SULFIDE AGAR
1
Cleared 510(K)
K
82
3072
LECITHIN LACTOSE AGAR
1
Cleared 510(K)
K
82
1592
TRIPLE SUGAR IRON AGAR SLANT
1
Cleared 510(K)
K
82
0842
CULTURE MEDIA, NON-SELECTIVE/DIFFER
1
Cleared 510(K)
K
82
0841
CULTURE MEDIA, MULTIPLE BIOCHEMICAL
1
Cleared 510(K)
K
82
0810
#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE
1
Cleared 510(K)
K
82
0214
SUCROSE
1
Cleared 510(K)
K
81
2911
BCYE MEDIUM
1
Cleared 510(K)
K
81
2466
ONPX-INDOL MEDIUM MICROTUBES
1
Cleared 510(K)
K
81
2467
PGUA-INDOL MICROTUBE
1
Cleared 510(K)
K
80
0734
RAPID FERMENTATION AGAR (RFA)
1
Cleared 510(K)
K
79
2420
SIM MEDIUM
1
Cleared 510(K)
K
79
2425
DECARBOXYLASE MOELLER BASE WITH OR WITH-
1
Cleared 510(K)
K
79
1473
TRIPLE SUGAR IRON AGAR (TSI AGAR)
1
Cleared 510(K)
K
79
1222
API 20E REAGENT QC
1
Cleared 510(K)
K
79
0617
CARBOHYDRATE FERMENTATION MEDIA
1
Cleared 510(K)
K
79
0232
AGAR, MOTILITY-NITRATE
1
Cleared 510(K)
K
79
0230
DENTRIFICATION LACTOSE AGAR
1
Cleared 510(K)
K
78
1856
PLATE, LD PRESUMPTO
1
Cleared 510(K)
K
77
0989
API 50 E
1
Cleared 510(K)
K
77
0746
PANEL, IDENTIFICATION, STREP, MICRO-ID
1
Cleared 510(K)
K
77
0176
API 3S
1
Cleared 510(K)
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
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
/
JSE
/
K822998
View Source
CHRISTENSENS CITRATE SULFIDE AGAR
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K822998
510(k) Type
Traditional
Applicant
GRANITE DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/1982
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
K
96
2265
MLX MICROTITER PLATE LUMINOMETER
K
88
3995
X-ACT UREA/TDA
K
88
3996
X-ACT LDC/IND
K
88
0133
MIL MEDIUM
K
88
0116
MRVP BROTH
K
87
4537
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K
87
1096
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
K
86
4674
MICRODILUTION IDENTIFICATION PANELS
K
86
2393
BIOTIS LITMUS MILK
K
86
0415
BIOTIS SIMMON CITRATE AGAR
K
86
0413
BIOTIS TSI
K
86
0414
BIOTIS ORNITHINE INDOLE MOTILITY MEDIA
K
86
0415
BIOTIS SIMMON CITRATE AGAR
K
86
0194
AUSTIN ENTERIC SYSTEM
K
85
0982
CTAPI - NEISSERA SCREEN
K
85
0734
DIFFERENTIAL CULTURE MEDIUM
K
85
0546
KLIGLER IRON AGAR KIA
K
85
0551
SIM MEDIUM
K
85
0548
LYSINE IRON AGAR LIA
K
85
0547
MOTILITY INDOLE ORNITHINE AGAR
K
84
3768
BIOTIS KLIGLER IRON AGAR
K
84
2451
RIM STREP KIT
K
84
2424
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K
84
1204
MULTIPLE BIOCHEMICAL TEST
K
83
4002
LYSINE IRON AGAR
K
83
4012
SIM MEDIUM
K
83
4004
MYCOBIOTIC AGAR
K
83
4003
MOTILITY INDOLE ORNITHINE-MEDIUM
K
83
4001
KLIGLER IRON AGAR
K
83
2568
INDOLE NITRATE MEDIUM
K
83
0525
API 20GP
K
82
2998
CHRISTENSENS CITRATE SULFIDE AGAR
K
82
3072
LECITHIN LACTOSE AGAR
K
82
1592
TRIPLE SUGAR IRON AGAR SLANT
K
82
0842
CULTURE MEDIA, NON-SELECTIVE/DIFFER
K
82
0841
CULTURE MEDIA, MULTIPLE BIOCHEMICAL
K
82
0810
#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE
K
82
0214
SUCROSE
K
81
2911
BCYE MEDIUM
K
81
2466
ONPX-INDOL MEDIUM MICROTUBES
K
81
2467
PGUA-INDOL MICROTUBE
K
80
0734
RAPID FERMENTATION AGAR (RFA)
K
79
2420
SIM MEDIUM
K
79
2425
DECARBOXYLASE MOELLER BASE WITH OR WITH-
K
79
1473
TRIPLE SUGAR IRON AGAR (TSI AGAR)
K
79
1222
API 20E REAGENT QC
K
79
0617
CARBOHYDRATE FERMENTATION MEDIA
K
79
0232
AGAR, MOTILITY-NITRATE
K
79
0230
DENTRIFICATION LACTOSE AGAR
K
78
1856
PLATE, LD PRESUMPTO
K
77
0989
API 50 E
K
77
0746
PANEL, IDENTIFICATION, STREP, MICRO-ID
K
77
0176
API 3S
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
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
/
JSE
/
K822998
View Source
CHRISTENSENS CITRATE SULFIDE AGAR
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K822998
510(k) Type
Traditional
Applicant
GRANITE DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/1982
Days to Decision
35 days