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- 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
- K242576AllTest Viral Transport Medium1Cleared 510(K)
- K232565UriSponge™1Cleared 510(K)
- K220908Ensol EnTM Specimen Collection and Transport System1Cleared 510(K)
- K240235OmniTrans Transport System1Cleared 510(K)
- K233534Viral Transport Medium1Cleared 510(K)
- K233449Avantik VTM1Cleared 510(K)
- K232454Viral Transport Media (VTM)1Cleared 510(K)
- K232357Copan Universal Transport Medium (UTM-RT) System1Cleared 510(K)
- K202531Azer Scientific Universal Transport Medium1Cleared 510(K)
- K231843ARX Viral Transport Media Collection and Transport System1Cleared 510(K)
- K231027KaiBiLi Extended ViralTrans1Cleared 510(K)
- K212743MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System1Cleared 510(K)
- K230035BioSci™ Disposable Virus Sampling Tubes1Cleared 510(K)
- K220052Copan FecalSwab Collection, Transport and Preservation System1Cleared 510(K)
- K220739Disposable Urine Collection Tube1Cleared 510(K)
- K212856iClean Viral Transport System (VTM-RT kit)1Cleared 510(K)
- K211256Disposable Sampler Viral Transport Media1Cleared 510(K)
- K211707BioTeke Sterile Disposable Virus Sampling Kit1Cleared 510(K)
- K201674Cultura Collection and Transport System1Cleared 510(K)
- K180052UriSwab-Urine Collection, Transport and Preservation System1Cleared 510(K)
- K163436Greiner Vacuette Urine Count and Culture, Mannitol tube1Cleared 510(K)
- K162284Puritan Fecal Opti-Swab Collection and Transport System1Cleared 510(K)
- K160082Puritan Opti-Tranz Cary-Blair Collection and Transport System1Cleared 510(K)
- K150887Para-Fix C&S Medium1Cleared 510(K)
- K142094COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM1Cleared 510(K)
- K141506MCC Para-Fix CARY BLAIR MEDIUM1Cleared 510(K)
- K142366Puritan OptiTranz Liquid Stuart Collection and Transport System1Cleared 510(K)
- K113249TRANSPORT CULTURE MEDIUM DEVICE1Cleared 510(K)
- K042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM1Cleared 510(K)
- K032246MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K024237URINE MONOVETTE BORIC ACID1Cleared 510(K)
- K024240BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS1Cleared 510(K)
- K001780COPAN VIRAL TRANSYSTEM1Cleared 510(K)
- K993812CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K1Cleared 510(K)
- K972726SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K970597CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)1Cleared 510(K)
- K965150A.C.T. IV1Cleared 510(K)
- K965149A.C.T. I1Cleared 510(K)
- K965152A.C.T. II1Cleared 510(K)
- K965151A.C.T. III1Cleared 510(K)
- K964637CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA1Cleared 510(K)
- K962843MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K96104610B ARGININE BROTH1Cleared 510(K)
- K955451CVM TRANSPORT1Cleared 510(K)
- K946284COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL1Cleared 510(K)
- K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM1Cleared 510(K)
- K946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM1Cleared 510(K)
- K946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL1Cleared 510(K)
- K946286COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM1Cleared 510(K)
- K946285COPAN VENTURI TRANSYSTEM STUARTS MEDIUM1Cleared 510(K)
- K943499KULTSURE STARSWAB(M240), MODIFICATION1Cleared 510(K)
- K943498KULTSURE STARSWAB (M210), MODIFICATION1Cleared 510(K)
- K941579MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)1Cleared 510(K)
- K936078CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED1Cleared 510(K)
- K932337CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K935987FLEXTRANS1Cleared 510(K)
- K935618SPECIMEN TRANSPORT MEDIUM1Cleared 510(K)
- K931922DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT1Cleared 510(K)
- K921472M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)1Cleared 510(K)
- K914894VIRAPURE, CHLAMYPURE AND MYCOPURE1Cleared 510(K)
- K913789AEROBIC FOAM SWAB CULTURETTE(R)1Cleared 510(K)
- K910180BACTI-SWAB1Cleared 510(K)
- K910526MICROTEST MULTI MICROBE MEDIUM1Cleared 510(K)
- K885245CARY-BLAIR TRANSPORT SYSTEM1Cleared 510(K)
- K885244SAF FECAL COLLECTION KIT1Cleared 510(K)
- K881105CULTURE COLLECTION DEVICE1Cleared 510(K)
- K881569STUARTS TRANSPORT MEDIUM1Cleared 510(K)
- K881539AMIES TRANSPORT MEDIUM1Cleared 510(K)
- K881529CARY AND BLAIR TRANSPORT MEDIUM1Cleared 510(K)
- K872507PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II1Cleared 510(K)
- K872213TRANSTUBE MW176 OT MD1761Cleared 510(K)
- K871404KULTSURE1Cleared 510(K)
- K864998IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT1Cleared 510(K)
- K871065CHLAMYDIA & VIRAL TRANSPORT MEDIUM1Cleared 510(K)
- K864237CARY BLAIR TRANSPORT MEDIUM1Cleared 510(K)
- K863682PATHFINDER(TM) SPECIMEN COLLECTION KIT1Cleared 510(K)
- K863602BUFFERED GLYCEROL SALINE1Cleared 510(K)
- K863527CARY-BLAIR TRANSPORT MEDIUM1Cleared 510(K)
- K863164AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA1Cleared 510(K)
- K861080CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)1Cleared 510(K)
- K860178KULTSURE (CULTURE TRANSPORT)1Cleared 510(K)
- K860656KULTSURE (CATALOGUE NO. M210)1Cleared 510(K)
- K860657KULTSURE (CATALOGUE NO. M240)1Cleared 510(K)
- K860658KULTSURE (CATALOGUE NO. M250)1Cleared 510(K)
- K854986BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU1Cleared 510(K)
- K854715TRANSPORT CULTURE MEDIA1Cleared 510(K)
- K854061SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM1Cleared 510(K)
- K853500ORTHO VIRAL TRANSPORT1Cleared 510(K)
- K850717AMIES TRANSPORT MEDIA1Cleared 510(K)
- K850124CHLAMYDIAL TRANSPORT MEDIA1Cleared 510(K)
- K844634PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS1Cleared 510(K)
- K844747VIRAL TRANSPORT MEDIA1Cleared 510(K)
- K844369BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO1Cleared 510(K)
- K844370BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT1Cleared 510(K)
- K841205NON PROPAGATING TRANSPORT1Cleared 510(K)
- K834125CHLAMYDIAL TRANSPORT MEDIUM1Cleared 510(K)
- K834316WATER W/TWEEN 801Cleared 510(K)
- K834315STERILE SALINE 0.85%1Cleared 510(K)
- K831159I/A KIT1Cleared 510(K)
- K831059P & T MEDIUM1Cleared 510(K)
- K823179CHLAMYDIA TRANSETTEE 1 & 31Cleared 510(K)
- K822886GONORRHEA TRANSETTE 31Cleared 510(K)
- K802303VIRAL TRANSPORT MED. (46-995-04)1Cleared 510(K)
- K800832VIRAL CULTURETTE HANK'S BAL. SALT SOL.1Cleared 510(K)
- K792712PARA-PAK (C&S)1Cleared 510(K)
- K791545TRANSPORT MEDIUM AMIES1Cleared 510(K)
- K791543TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL1Cleared 510(K)
- K791515TRANSPORT MEDIUM STUART W/ CHARCOAL1Cleared 510(K)
- K791514TRANSPORT MEDIUM STUART1Cleared 510(K)
- 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
Puritan Fecal Opti-Swab Collection and Transport System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K162284
- 510(k) Type
- Traditional
- Applicant
- PURITAN MEDICAL PRODUCTS LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/4/2016
- Days to Decision
- 81 days
- Submission Type
- Summary