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
- K881949ATS NAC-PAC SET1Cleared 510(K)
- K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-421Cleared 510(K)
- K881566HEMOGLOBIN POWDER1Cleared 510(K)
- K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE1Cleared 510(K)
- K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)1Cleared 510(K)
- K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)1Cleared 510(K)
- K861791PENICILLIN-STREPTOMYCIN-FUNGIZONE1Cleared 510(K)
- K855172KWI (TM) G-CO/TWO1Cleared 510(K)
- K853546ABBOTT CATION SUPPLEMENT SOLUTION1Cleared 510(K)
- K850302SUPLEX & SUPLEX DILUENT1Cleared 510(K)
- K850738SUPPLEMENT FOR CULTURE MEDIUM1Cleared 510(K)
- K850299C.N.V.T.1Cleared 510(K)
- K850307CAMPYLOBACTER SUPPLEMENT-BLASER/WANG1Cleared 510(K)
- K850308C.L.A.T.1Cleared 510(K)
- K850306CAMPYLOBACTER SUPPLEMENT -SKIRROW1Cleared 510(K)
- K850300MUCOLYSE1Cleared 510(K)
- K850301YEAST DIALYSATE1Cleared 510(K)
- K840331LEGIONELLA MWY SELECTIVE SUPPLEMENT1Cleared 510(K)
- K840330PRESTON CAMPYLOBACTER SELECTIVE SUPP1Cleared 510(K)
- K840333LEGIONELLA BMPA SELECTIVE SUPPLE1Cleared 510(K)
- K834115CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT1Cleared 510(K)
- K834066TINSDALE ENRICHMENT1Cleared 510(K)
- K833210LACTOSE1Cleared 510(K)
- K833018CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW1Cleared 510(K)
- K833020CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER1Cleared 510(K)
- K833019CAMPYLOBACTER SELECTIVE SUPPLE-BLASER1Cleared 510(K)
- K832902MIDDLEBROOK ADC ENRICHMENT1Cleared 510(K)
- K831469LEGIONELLA CYE AGAR BASE & BCYE SUPPL1Cleared 510(K)
- K831219CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE1Cleared 510(K)
- K820610GELRITE1Cleared 510(K)
- K822511YERSINIA SELECTIVE SUPPLEMENT1Cleared 510(K)
- K822459VCAT ANTIBIOTIC SUPPLEMENT1Cleared 510(K)
- K822460LCAT ANTIBIOTIC SUPPLEMENT1Cleared 510(K)
- K822461N-S ANAEROBE SUPPLEMENT1Cleared 510(K)
- K822462G-N ANAEROBE SUPPLEMENT1Cleared 510(K)
- K822458YEAST AUTOLYXATE SUPPLEMENT1Cleared 510(K)
- K811732THIOTONE PEPTONE1Cleared 510(K)
- K811730BIOSATE1Cleared 510(K)
- K811649GELYSATE1Cleared 510(K)
- K811652POLYPEPTONE PEPTONE1Cleared 510(K)
- K811653PHYTONE1Cleared 510(K)
- K811518VCNT ANTIBIOTIC SUPPLEMENT1Cleared 510(K)
- K811516LEGIONELLA, GROWTH & SELECTIVE, SUPP.1Cleared 510(K)
- K811517VCN SUPPLEMENT1Cleared 510(K)
- K811225HUMAN BLOOD IN ALSEVER'S1Cleared 510(K)
- K811360YEAST EXTRACT1Cleared 510(K)
- K811361PANCREATIC HYDROLYSATE OF HEART MUSCLE1Cleared 510(K)
- K811357HEMOGLOBIN POWDER1Cleared 510(K)
- K810932VITOX1Cleared 510(K)
- K810591PACT SUPPLEMENT1Cleared 510(K)
- K802753CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)1Cleared 510(K)
- K800265BORDETELLA SELECTIVE SUPPLEMENT1Cleared 510(K)
- K800264CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT1Cleared 510(K)
- K800263PERFRINGENS SUPPLEMENT B1Cleared 510(K)
- K800262PERFRINGENS SUPPLEMENT A1Cleared 510(K)
- K800261DERMASEL SUPPLEMENT1Cleared 510(K)
- K800260STREPTOCOCCUS SUPPLEMENT1Cleared 510(K)
- K800259OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT1Cleared 510(K)
- K800258STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT1Cleared 510(K)
- K800257CAMPYLOBACTER SELECTIVE SUPPLEMENT1Cleared 510(K)
- K800256TINSDALE SUPPLEMENT1Cleared 510(K)
- K800255STERILE GC SUPPLEMENT (W/O ANTIBIOTICS)1Cleared 510(K)
- K800254MYCOPLASMA SUPPLEMENT P1Cleared 510(K)
- K800252STERILE GC SUPPLEMENT1Cleared 510(K)
- K800253MYCOPLASMA SUPPLEMENT G1Cleared 510(K)
- K800267CAMPYLOBACTER SELECTIVE SUPPLEMENT1Cleared 510(K)
- K800266CAMPYLOBACTER GROWTH SUPPLEMENT1Cleared 510(K)
- K790801STERILE DEFIBRINATED SHEEP BLOOD1Cleared 510(K)
- K780306LYOPHILIZED VIALS OF VCA AND VCAT1Cleared 510(K)
- K760589VCA INHIBITOR1Cleared 510(K)
- 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
- 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
SUPPLEMENT FOR CULTURE MEDIUM
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K850738
- 510(k) Type
- Traditional
- Applicant
- ROSEVILLE MEDICAL LABORATORIESU
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/20/1985
- Days to Decision
- 28 days