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
- 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
- K222613ARX Liquid Amies Collection & Transport System1Cleared 510(K)
- K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K120846TRANSPORT CULTURE MEDIUM DEVICE1Cleared 510(K)
- K103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE1Cleared 510(K)
- K082472VIROCULT, MODEL MW9501Cleared 510(K)
- K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE1Cleared 510(K)
- K013711BACTI-SWAB DRY1Cleared 510(K)
- K003761NAT - NUCLEIC ACID TRANSPORT1Cleared 510(K)
- K983119ENTERO-TEST HP, MODEL #102-011Cleared 510(K)
- K981391PAR-ONE1Cleared 510(K)
- K964144PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF1Cleared 510(K)
- K963986STP SYSTEM PVA WITH ZINC1Cleared 510(K)
- K964026STP SYSTEM - SAF1Cleared 510(K)
- K964027STP SYSTEM-PVA WITH MERCURY1Cleared 510(K)
- K960997STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K953929MID-STREAM COLLECTION SET-STERILE1Cleared 510(K)
- K950096PINWORM EGG COLLECTOR1Cleared 510(K)
- K931770PARA-PAK PLUS1Cleared 510(K)
- K931383ZINC PVA1Cleared 510(K)
- K930313APEX SPECIMEN BAG1Cleared 510(K)
- K924053CYTOQUANT COMBINED TRANSPORT MEDIA1Cleared 510(K)
- K924330TRANSYSTEM AMIES WITH CHARCOAL1Cleared 510(K)
- K924328TRANSYSTEM LIQUID AMIES MEDIUM1Cleared 510(K)
- K924329TRANSYSTEM AMIES W/O CHARCOAL1Cleared 510(K)
- K924331TRANSYSTEM LIQUID STUART MEDIUM1Cleared 510(K)
- K920536AFFIRM VP SAMPLE COLLECTION SET1Cleared 510(K)
- K920761URINE CULTUR STABILIZATION TRANSPORT TUBE1Cleared 510(K)
- K915454CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT1Cleared 510(K)
- K912832BACTI-SWAB(TM) NPG1Cleared 510(K)
- K912831BACTI-SWAB(TM) II1Cleared 510(K)
- K903638GASTRO-INTESTINAL ACCU-CULSHURE TM1Cleared 510(K)
- K905120SAF FIXATIVE1Cleared 510(K)
- K903405CHLAMYDIA ACCU-CULSHURE TM1Cleared 510(K)
- K903406VIRAL ACCU-CULSHURE TM1Cleared 510(K)
- K902467FLORA-STAT URINE TRANSPORT SYSTEM1Cleared 510(K)
- K896794SPECIMEN CONTAINER1Cleared 510(K)
- K900225ROMCHECK SPECIMEN COLLECTION KIT1Cleared 510(K)
- K893905PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)1Cleared 510(K)
- K890134FTK FECAL TRANSPORT KIT1Cleared 510(K)
- K884342NOVAPATH SPECIMEN COLLECTION KIT1Cleared 510(K)
- K882485DIVERSI-KIT1Cleared 510(K)
- K873565SNAP(R) ROTAVIRUS DIAGNOSTIC KIT1Cleared 510(K)
- K881125PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT1Cleared 510(K)
- K874456CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT1Cleared 510(K)
- K872751FLUORTRAN - C(TM)1Cleared 510(K)
- K871860NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT1Cleared 510(K)
- K870963MODIFIED PATHFINDER SPECIMEN COLLECTION KIT1Cleared 510(K)
- K870231KULTSURE1Cleared 510(K)
- K864727CULT-UR1Cleared 510(K)
- K862607IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT1Cleared 510(K)
- K860655KULTSURE (CATALOGUE NO. M200)1Cleared 510(K)
- K854719LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)1Cleared 510(K)
- K851378VIRTRAN VIRAL TRANPORTER1Cleared 510(K)
- K851387MICROSTATIC URINE TRANSPORT TUBE FOR C & S1Cleared 510(K)
- K843000MICRO ORGANISM GROWTH SYS-M10001Cleared 510(K)
- K843935MODIFICATION MICROTRAK DIRECT SPECIMEN TEST1Cleared 510(K)
- K840799V.D.T.-GONORRHEA TEST KIT1Cleared 510(K)
- K833814SANI CATCH BA1Cleared 510(K)
- K834566PRESERV SAF FIXATIVE 15ML1Cleared 510(K)
- K840086PRESERV MF FIXATIVE 15ML1Cleared 510(K)
- K832079COLLECTION KIT CHLAMYDIA TRACHOMATIS1Cleared 510(K)
- K832246DUPONT ISOLATOR 1.5 MICROBIAL TUBE1Cleared 510(K)
- K820520VD ALERT1Cleared 510(K)
- 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
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K862607
- 510(k) Type
- Traditional
- Applicant
- BOOTS-CELLTECH DIAGNOSTICS, INC.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/4/1986
- Days to Decision
- 27 days