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
- K210511InTray GC2Cleared 510(K)
- K993033INTRAY GC2Cleared 510(K)
- K954986GC BASE W/ 1% GCHI2Cleared 510(K)
- K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA2Cleared 510(K)
- K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR2Cleared 510(K)
- K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR2Cleared 510(K)
- K934331THAYER MARTIN, MODIFIED PILL POCKET2Cleared 510(K)
- K934330TRANSGROW2Cleared 510(K)
- K931864MARTIN LEWIS WITH LINOCMYCIN2Cleared 510(K)
- K881552PROTEOSE NO. 3 AGAR2Cleared 510(K)
- K881552PROTEOSE NO. 3 AGAR2Cleared 510(K)
- K871541MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C02262Cleared 510(K)
- K864253THAYER MARTIN AGAR2Cleared 510(K)
- K864252THAYER-MARTIN JEMBEC2Cleared 510(K)
- K864803GC-LECT(TM)2Cleared 510(K)
- K864078MODIFIED N.Y.C. FERMENTATION MEDIUM BASE2Cleared 510(K)
- K860384BIOTIS MODIFIED THAYER MARTIN2Cleared 510(K)
- K854275THAYER-MARTIN MEDIUM (MOD)2Cleared 510(K)
- K853237APL MARTIN LEWIS MEDIUM2Cleared 510(K)
- K851579CHOCOLATE MUELLER HINTON AGAR2Cleared 510(K)
- K851587THAYER MARTIN AGAR & MODIFIED THAYER AGAR2Cleared 510(K)
- K850722MARTIN LEWIS AGAR2Cleared 510(K)
- K850841MOD THAYER MARTIN MARTIN LEWIS2Cleared 510(K)
- K850732CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI2Cleared 510(K)
- K844014ONO/CO-TWO (TM) SYSTEMS2Cleared 510(K)
- K843817BIOTIS MARTIN LEWIS AGAR2Cleared 510(K)
- K841750MARTIN-LEWIS AGAR2Cleared 510(K)
- K841833CULTURE MEDIUM FOR PATHOGENIC NEISSER2Cleared 510(K)
- K840970CULTURE MEDIUM FOR PATHOGENIC NEISSER2Cleared 510(K)
- K840065CHOCOLATE AGAR GC BASE PLATE2Cleared 510(K)
- K840067THAYER-MARTIN AGAR PLATE2Cleared 510(K)
- K840159GC-TECT2Cleared 510(K)
- K833862THAYER MARTIN AGAR2Cleared 510(K)
- K832948NYC-GC MEDIA2Cleared 510(K)
- K832862TRANSGROW MEDIUM2Cleared 510(K)
- K832612CHOCOLATE AGAR & THAYER MARTIN AGAR2Cleared 510(K)
- K831359MODIFIED NEW YORK MEDIUM2Cleared 510(K)
- K831268TILL-U-TEST G.C. GONOCOCUS SLIDE2Cleared 510(K)
- K831124BIOCULT - GC CULTURE-PADDLES2Cleared 510(K)
- K830062MARTIN-LEWIS AGAR2Cleared 510(K)
- K830061THAYER-MARTIN, MODIFIED2Cleared 510(K)
- K823309MARTIN & LEMIS AGAR W/VCAT INHIBITOR2Cleared 510(K)
- K822552NY FERMENTATION MEDIA2Cleared 510(K)
- K821602THAYER MARTIN2Cleared 510(K)
- K821551MARTIN-LEWIS/PRONG AGAR2Cleared 510(K)
- K820847ISOLATION OF PATHOGENIC NEISSERIA2Cleared 510(K)
- K812078GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)2Cleared 510(K)
- K811645THAYER-MARTIN, GC AGAR BASE2Cleared 510(K)
- K811479CHODOLATE AGAR, ENRICHED2Cleared 510(K)
- K811476THAYER MARTIN AGAR2Cleared 510(K)
- K811382LAB-TEK JEMBEC G.C. CULTURE SYSTEM2Cleared 510(K)
- K811281GC CULTURE MEDIUM2Cleared 510(K)
- K811282SELECTIVE GC CULTURE MEDIUM2Cleared 510(K)
- K811053GC AGAR2Cleared 510(K)
- K800977THAYER-MARTIN AGAR2Cleared 510(K)
- K800334MARTIN-LEWIS AGAR2Cleared 510(K)
- K800333MODIFIED THAYER-MARTIN X AGAR2Cleared 510(K)
- K791557MARTIN-LEWIS AGAR (PLATE)2Cleared 510(K)
- K791554TRANSGROW2Cleared 510(K)
- K791447MARTIN LEWIS AGAR CSI 31692Cleared 510(K)
- K791446MARTIN LEWIS JEMBEC CSI 88722Cleared 510(K)
- K791425MODIFIED THAYER-MARTIN AGAR (PLATE)2Cleared 510(K)
- K791398CULTURE MEDIA FOR INSOLATION NEISSERIA2Cleared 510(K)
- K791483THAYER-MARTIN MEDIUM2Cleared 510(K)
- K791470MODIFIED THAYER-MARTIN MEDIUM2Cleared 510(K)
- K790368MODIFIED THAYER MARTIN AGAR2Cleared 510(K)
- K782117MARTIN-LEWIS MEDIUM2Cleared 510(K)
- K780022CULTURE MEDIA/ISOLA. PATHO. NEISSERIA2Cleared 510(K)
- K771871MARTIN LEWIS AGAR (PLATE)2Cleared 510(K)
- K771872MARTIN LEWIS TRANSGROW2Cleared 510(K)
- K771870MARTIN LEWIS AGAR (JEMBEC)2Cleared 510(K)
- K771035CULTURE TEST FOR NEISSERIA GONORRHOEAE2Cleared 510(K)
- K770925IMPROVED THAYER-MARTIN MEDIUM2Cleared 510(K)
- K770874IMPROVED THAYER MARTIN (PLATE)2Cleared 510(K)
- K770876IMPROVED TRANSGROW2Cleared 510(K)
- K770875IMPROVED THAYER MARTIN (JEMBEC)2Cleared 510(K)
- K770287MARTIN-LEWIS AGAR MEDIUM2Cleared 510(K)
- K760598IMPROVED THAYER MARTIN MEDIUM2Cleared 510(K)
- K760693NEIGON JEMBEC PLATE WITH ANIXOMYCIN2Cleared 510(K)
- K760692MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN2Cleared 510(K)
- K760691THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L2Cleared 510(K)
- K760690THAYER-MARTIN MEDIUM WITH ANSIOMYCIN2Cleared 510(K)
- K760588IMPROVED THAYER MARTIN MEDIUM2Cleared 510(K)
- 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
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K812078
- 510(k) Type
- Traditional
- Applicant
- ABBOTT LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent - PostMarket Surveillance Required
- Decision Date
- 7/23/1981
- Days to Decision
- 0 days