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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
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
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
K
24
2576
AllTest Viral Transport Medium
1
Cleared 510(K)
K
23
2565
UriSponge™
1
Cleared 510(K)
K
22
0908
Ensol EnTM Specimen Collection and Transport System
1
Cleared 510(K)
K
24
0235
OmniTrans Transport System
1
Cleared 510(K)
K
23
3534
Viral Transport Medium
1
Cleared 510(K)
K
23
3449
Avantik VTM
1
Cleared 510(K)
K
23
2454
Viral Transport Media (VTM)
1
Cleared 510(K)
K
23
2357
Copan Universal Transport Medium (UTM-RT) System
1
Cleared 510(K)
K
20
2531
Azer Scientific Universal Transport Medium
1
Cleared 510(K)
K
23
1843
ARX Viral Transport Media Collection and Transport System
1
Cleared 510(K)
K
23
1027
KaiBiLi Extended ViralTrans
1
Cleared 510(K)
K
21
2743
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
1
Cleared 510(K)
K
23
0035
BioSci™ Disposable Virus Sampling Tubes
1
Cleared 510(K)
K
22
0052
Copan FecalSwab Collection, Transport and Preservation System
1
Cleared 510(K)
K
22
0739
Disposable Urine Collection Tube
1
Cleared 510(K)
K
21
2856
iClean Viral Transport System (VTM-RT kit)
1
Cleared 510(K)
K
21
1256
Disposable Sampler Viral Transport Media
1
Cleared 510(K)
K
21
1707
BioTeke Sterile Disposable Virus Sampling Kit
1
Cleared 510(K)
K
20
1674
Cultura Collection and Transport System
1
Cleared 510(K)
K
18
0052
UriSwab-Urine Collection, Transport and Preservation System
1
Cleared 510(K)
K
16
3436
Greiner Vacuette Urine Count and Culture, Mannitol tube
1
Cleared 510(K)
K
16
2284
Puritan Fecal Opti-Swab Collection and Transport System
1
Cleared 510(K)
K
16
0082
Puritan Opti-Tranz Cary-Blair Collection and Transport System
1
Cleared 510(K)
K
15
0887
Para-Fix C&S Medium
1
Cleared 510(K)
K
14
2094
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
1
Cleared 510(K)
K
14
1506
MCC Para-Fix CARY BLAIR MEDIUM
1
Cleared 510(K)
K
14
2366
Puritan OptiTranz Liquid Stuart Collection and Transport System
1
Cleared 510(K)
K
11
3249
TRANSPORT CULTURE MEDIUM DEVICE
1
Cleared 510(K)
K
04
2970
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
1
Cleared 510(K)
K
03
2246
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
1
Cleared 510(K)
K
02
4237
URINE MONOVETTE BORIC ACID
1
Cleared 510(K)
K
02
4240
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
1
Cleared 510(K)
K
00
1780
COPAN VIRAL TRANSYSTEM
1
Cleared 510(K)
K
99
3812
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
1
Cleared 510(K)
K
97
2726
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
1
Cleared 510(K)
K
97
0597
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
1
Cleared 510(K)
K
96
5150
A.C.T. IV
1
Cleared 510(K)
K
96
5149
A.C.T. I
1
Cleared 510(K)
K
96
5152
A.C.T. II
1
Cleared 510(K)
K
96
5151
A.C.T. III
1
Cleared 510(K)
K
96
4637
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
1
Cleared 510(K)
K
96
2843
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
1
Cleared 510(K)
K
96
1046
10B ARGININE BROTH
1
Cleared 510(K)
K
95
5451
CVM TRANSPORT
1
Cleared 510(K)
K
94
6284
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
1
Cleared 510(K)
K
94
6283
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
1
Cleared 510(K)
K
94
6288
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM
1
Cleared 510(K)
K
94
6287
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
1
Cleared 510(K)
K
94
6286
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
1
Cleared 510(K)
K
94
6285
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM
1
Cleared 510(K)
K
94
3499
KULTSURE STARSWAB(M240), MODIFICATION
1
Cleared 510(K)
K
94
3498
KULTSURE STARSWAB (M210), MODIFICATION
1
Cleared 510(K)
K
94
1579
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)
1
Cleared 510(K)
K
93
6078
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
1
Cleared 510(K)
K
93
2337
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
1
Cleared 510(K)
K
93
5987
FLEXTRANS
1
Cleared 510(K)
K
93
5618
SPECIMEN TRANSPORT MEDIUM
1
Cleared 510(K)
K
93
1922
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT
1
Cleared 510(K)
K
92
1472
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)
1
Cleared 510(K)
K
91
4894
VIRAPURE, CHLAMYPURE AND MYCOPURE
1
Cleared 510(K)
K
91
3789
AEROBIC FOAM SWAB CULTURETTE(R)
1
Cleared 510(K)
K
91
0180
BACTI-SWAB
1
Cleared 510(K)
K
91
0526
MICROTEST MULTI MICROBE MEDIUM
1
Cleared 510(K)
K
88
5244
SAF FECAL COLLECTION KIT
1
Cleared 510(K)
K
88
5245
CARY-BLAIR TRANSPORT SYSTEM
1
Cleared 510(K)
K
88
1105
CULTURE COLLECTION DEVICE
1
Cleared 510(K)
K
88
1569
STUARTS TRANSPORT MEDIUM
1
Cleared 510(K)
K
88
1529
CARY AND BLAIR TRANSPORT MEDIUM
1
Cleared 510(K)
K
88
1539
AMIES TRANSPORT MEDIUM
1
Cleared 510(K)
K
87
2507
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
1
Cleared 510(K)
K
87
2213
TRANSTUBE MW176 OT MD176
1
Cleared 510(K)
K
87
1404
KULTSURE
1
Cleared 510(K)
K
86
4998
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
1
Cleared 510(K)
K
87
1065
CHLAMYDIA & VIRAL TRANSPORT MEDIUM
1
Cleared 510(K)
K
86
4237
CARY BLAIR TRANSPORT MEDIUM
1
Cleared 510(K)
K
86
3682
PATHFINDER(TM) SPECIMEN COLLECTION KIT
1
Cleared 510(K)
K
86
3602
BUFFERED GLYCEROL SALINE
1
Cleared 510(K)
K
86
3527
CARY-BLAIR TRANSPORT MEDIUM
1
Cleared 510(K)
K
86
3164
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
1
Cleared 510(K)
K
86
1080
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)
1
Cleared 510(K)
K
86
0178
KULTSURE (CULTURE TRANSPORT)
1
Cleared 510(K)
K
86
0658
KULTSURE (CATALOGUE NO. M250)
1
Cleared 510(K)
K
86
0656
KULTSURE (CATALOGUE NO. M210)
1
Cleared 510(K)
K
86
0657
KULTSURE (CATALOGUE NO. M240)
1
Cleared 510(K)
K
85
4986
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
1
Cleared 510(K)
K
85
4715
TRANSPORT CULTURE MEDIA
1
Cleared 510(K)
K
85
4061
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
1
Cleared 510(K)
K
85
3500
ORTHO VIRAL TRANSPORT
1
Cleared 510(K)
K
85
0717
AMIES TRANSPORT MEDIA
1
Cleared 510(K)
K
85
0124
CHLAMYDIAL TRANSPORT MEDIA
1
Cleared 510(K)
K
84
4634
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
1
Cleared 510(K)
K
84
4747
VIRAL TRANSPORT MEDIA
1
Cleared 510(K)
K
84
4370
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
1
Cleared 510(K)
K
84
4369
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
1
Cleared 510(K)
K
84
1205
NON PROPAGATING TRANSPORT
1
Cleared 510(K)
K
83
4125
CHLAMYDIAL TRANSPORT MEDIUM
1
Cleared 510(K)
K
83
4316
WATER W/TWEEN 80
1
Cleared 510(K)
K
83
4315
STERILE SALINE 0.85%
1
Cleared 510(K)
K
83
1159
I/A KIT
1
Cleared 510(K)
K
83
1059
P & T MEDIUM
1
Cleared 510(K)
K
82
3179
CHLAMYDIA TRANSETTEE 1 & 3
1
Cleared 510(K)
K
82
2886
GONORRHEA TRANSETTE 3
1
Cleared 510(K)
K
80
2303
VIRAL TRANSPORT MED. (46-995-04)
1
Cleared 510(K)
K
80
0832
VIRAL CULTURETTE HANK'S BAL. SALT SOL.
1
Cleared 510(K)
K
79
2712
PARA-PAK (C&S)
1
Cleared 510(K)
K
79
1545
TRANSPORT MEDIUM AMIES
1
Cleared 510(K)
K
79
1543
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL
1
Cleared 510(K)
K
79
1515
TRANSPORT MEDIUM STUART W/ CHARCOAL
1
Cleared 510(K)
K
79
1514
TRANSPORT MEDIUM STUART
1
Cleared 510(K)
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 13 June 2025 at 11:06 pm
MI
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subpart-c—microbiology-devices
/
JSM
/
K850124
View Source
CHLAMYDIAL TRANSPORT MEDIA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K850124
510(k) Type
Traditional
Applicant
HILLCREST BIOLOGICALS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/1985
Days to Decision
49 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
JSJ
Culture Media, Selective And Non-Differential
JSK
Supplement, Culture Media
JSL
Culture Media, Anaerobic Transport
JSM
Culture Media, Non-Propagating Transport
K
24
2576
AllTest Viral Transport Medium
K
23
2565
UriSponge™
K
22
0908
Ensol EnTM Specimen Collection and Transport System
K
24
0235
OmniTrans Transport System
K
23
3534
Viral Transport Medium
K
23
3449
Avantik VTM
K
23
2454
Viral Transport Media (VTM)
K
23
2357
Copan Universal Transport Medium (UTM-RT) System
K
20
2531
Azer Scientific Universal Transport Medium
K
23
1843
ARX Viral Transport Media Collection and Transport System
K
23
1027
KaiBiLi Extended ViralTrans
K
21
2743
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
K
23
0035
BioSci™ Disposable Virus Sampling Tubes
K
22
0052
Copan FecalSwab Collection, Transport and Preservation System
K
22
0739
Disposable Urine Collection Tube
K
21
2856
iClean Viral Transport System (VTM-RT kit)
K
21
1256
Disposable Sampler Viral Transport Media
K
21
1707
BioTeke Sterile Disposable Virus Sampling Kit
K
20
1674
Cultura Collection and Transport System
K
18
0052
UriSwab-Urine Collection, Transport and Preservation System
K
16
3436
Greiner Vacuette Urine Count and Culture, Mannitol tube
K
16
2284
Puritan Fecal Opti-Swab Collection and Transport System
K
16
0082
Puritan Opti-Tranz Cary-Blair Collection and Transport System
K
15
0887
Para-Fix C&S Medium
K
14
2094
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K
14
1506
MCC Para-Fix CARY BLAIR MEDIUM
K
14
2366
Puritan OptiTranz Liquid Stuart Collection and Transport System
K
11
3249
TRANSPORT CULTURE MEDIUM DEVICE
K
04
2970
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
K
03
2246
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K
02
4237
URINE MONOVETTE BORIC ACID
K
02
4240
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
K
00
1780
COPAN VIRAL TRANSYSTEM
K
99
3812
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
K
97
2726
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K
97
0597
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
K
96
5150
A.C.T. IV
K
96
5149
A.C.T. I
K
96
5152
A.C.T. II
K
96
5151
A.C.T. III
K
96
4637
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
K
96
2843
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K
96
1046
10B ARGININE BROTH
K
95
5451
CVM TRANSPORT
K
94
6284
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K
94
6283
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
K
94
6288
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM
K
94
6287
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K
94
6286
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
K
94
6285
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM
K
94
3499
KULTSURE STARSWAB(M240), MODIFICATION
K
94
3498
KULTSURE STARSWAB (M210), MODIFICATION
K
94
1579
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)
K
93
6078
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
K
93
2337
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
K
93
5987
FLEXTRANS
K
93
5618
SPECIMEN TRANSPORT MEDIUM
K
93
1922
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT
K
92
1472
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)
K
91
4894
VIRAPURE, CHLAMYPURE AND MYCOPURE
K
91
3789
AEROBIC FOAM SWAB CULTURETTE(R)
K
91
0180
BACTI-SWAB
K
91
0526
MICROTEST MULTI MICROBE MEDIUM
K
88
5244
SAF FECAL COLLECTION KIT
K
88
5245
CARY-BLAIR TRANSPORT SYSTEM
K
88
1105
CULTURE COLLECTION DEVICE
K
88
1569
STUARTS TRANSPORT MEDIUM
K
88
1529
CARY AND BLAIR TRANSPORT MEDIUM
K
88
1539
AMIES TRANSPORT MEDIUM
K
87
2507
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K
87
2213
TRANSTUBE MW176 OT MD176
K
87
1404
KULTSURE
K
86
4998
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K
87
1065
CHLAMYDIA & VIRAL TRANSPORT MEDIUM
K
86
4237
CARY BLAIR TRANSPORT MEDIUM
K
86
3682
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K
86
3602
BUFFERED GLYCEROL SALINE
K
86
3527
CARY-BLAIR TRANSPORT MEDIUM
K
86
3164
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
K
86
1080
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)
K
86
0178
KULTSURE (CULTURE TRANSPORT)
K
86
0658
KULTSURE (CATALOGUE NO. M250)
K
86
0656
KULTSURE (CATALOGUE NO. M210)
K
86
0657
KULTSURE (CATALOGUE NO. M240)
K
85
4986
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
K
85
4715
TRANSPORT CULTURE MEDIA
K
85
4061
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
K
85
3500
ORTHO VIRAL TRANSPORT
K
85
0717
AMIES TRANSPORT MEDIA
K
85
0124
CHLAMYDIAL TRANSPORT MEDIA
K
84
4634
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
K
84
4747
VIRAL TRANSPORT MEDIA
K
84
4370
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
K
84
4369
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
K
84
1205
NON PROPAGATING TRANSPORT
K
83
4125
CHLAMYDIAL TRANSPORT MEDIUM
K
83
4316
WATER W/TWEEN 80
K
83
4315
STERILE SALINE 0.85%
K
83
1159
I/A KIT
K
83
1059
P & T MEDIUM
K
82
3179
CHLAMYDIA TRANSETTEE 1 & 3
K
82
2886
GONORRHEA TRANSETTE 3
K
80
2303
VIRAL TRANSPORT MED. (46-995-04)
K
80
0832
VIRAL CULTURETTE HANK'S BAL. SALT SOL.
K
79
2712
PARA-PAK (C&S)
K
79
1545
TRANSPORT MEDIUM AMIES
K
79
1543
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL
K
79
1515
TRANSPORT MEDIUM STUART W/ CHARCOAL
K
79
1514
TRANSPORT MEDIUM STUART
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
/
JSM
/
K850124
View Source
CHLAMYDIAL TRANSPORT MEDIA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K850124
510(k) Type
Traditional
Applicant
HILLCREST BIOLOGICALS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/1985
Days to Decision
49 days