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
- K880946NUTRIENT GELATIN - PRODUCT NUMBER T28601Cleared 510(K)
- K880119MOELLERS DECARBOXYLASE, ONITHINE1Cleared 510(K)
- K880126LAURYL TRYPTOSE BROTH1Cleared 510(K)
- K880120MOELLERS DECARBOXYLASE, LYSINE1Cleared 510(K)
- K880139ONPG TEST REAGENT1Cleared 510(K)
- K880106ACETAMIDE AGAR SLANT1Cleared 510(K)
- K880110CYSTINE TRYPTIC MEDIUM W/DEXTROSE1Cleared 510(K)
- K880135NITRATE BROTH1Cleared 510(K)
- K880111CYSTINE TRYPTIC MEDIUM W/SUCROSE1Cleared 510(K)
- K880112CYSTINE TRYPTIC MEDIUM W/ MALTOSE1Cleared 510(K)
- K880113CYSTINE TRYPTIC MEDIUM W/LACTOSE1Cleared 510(K)
- K880112CYSTINE TRYPTIC MEDIUM W/ MALTOSE1Cleared 510(K)
- K880111CYSTINE TRYPTIC MEDIUM W/SUCROSE1Cleared 510(K)
- K880115NUTRIENT GELATIN1Cleared 510(K)
- K874174BIOTIS (TM) STARCH HYDROLYSIS WITH BCP1Cleared 510(K)
- K874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC1Cleared 510(K)
- K873828CULTURE MEDIA T2995/2954/2992/2991/2993/2994/29901Cleared 510(K)
- K872691IAFP UREA AGAR SLANT1Cleared 510(K)
- K870641TRYPTONE BROTH, 2%1Cleared 510(K)
- K864256TRYPTONE WATER (1%)1Cleared 510(K)
- K864241DNASE AGAR1Cleared 510(K)
- K862392BIOTIS MOTILITY TEST MEDIUM1Cleared 510(K)
- K862398BIOTIS DECARBOXYLASE MEDIA, ORNITHINE1Cleared 510(K)
- K862397BIOTIS DECARBOXYLASE MEDIA, LYSINE1Cleared 510(K)
- K862396BIOTIS DECARBOXYLASE MEDIA, ARGININE1Cleared 510(K)
- K850194CAFFEIC ACID DISK1Cleared 510(K)
- K850550SIMMONS CITRATE AGAR1Cleared 510(K)
- K850545ACETATE DIFFERENTIAL AGAR1Cleared 510(K)
- K844543CYSTINE TRYPTIC AGAR W/LACTOSE1Cleared 510(K)
- K844545CYSTINE TRYPTIC AGAR W/MANNITOL1Cleared 510(K)
- K844546CYSTINE TRYPTIC AGAR W/SUCROSE1Cleared 510(K)
- K844544CYSTINE TRYPTIC AGAR W/MALTOSE1Cleared 510(K)
- K844542CYSTINE TRYPTIC AGAR W/DEXTROSE1Cleared 510(K)
- K844540CYSTINE TRYPTIC AGAR W/FRUCTOSE1Cleared 510(K)
- K844539PHENOL RED BROTH W/CARBOHYDRATES1Cleared 510(K)
- K843364DIFFERENTIATION DISKS BILE ESCULIN1Cleared 510(K)
- K842871HIPPURATE TEST REAGENT1Cleared 510(K)
- K842869DECARBOXYLASE TEST REAGENT1Cleared 510(K)
- K842867VOGES-PROSKAUER REAGENT B1Cleared 510(K)
- K842872INDOLE REAGENT1Cleared 510(K)
- K842870VOGES-PROSKAUER REAGENT A1Cleared 510(K)
- K842868HIPPURATE TEST DISKS1Cleared 510(K)
- K842853LYSINE IRON AGAR1Cleared 510(K)
- K842855CHRISTENSEN'S UREA AGAR1Cleared 510(K)
- K842600STREP-A-CHEK1Cleared 510(K)
- K842299ZINC DUST SUSPENSION1Cleared 510(K)
- K842298OXIDASE TEST STRIPS-OXIDASESURE1Cleared 510(K)
- K842300ONPG DISKS1Cleared 510(K)
- K842290SPOT TEST NINHYDRIN REAGENTS1Cleared 510(K)
- K842291SPOT TEST CATALASE TEST1Cleared 510(K)
- K842297ARGINIE BROTH1Cleared 510(K)
- K842098RIM H2S1Cleared 510(K)
- K842097RIM SPOT INDOLE1Cleared 510(K)
- K842072L-ALANINE-4-NITROANILIDE1Cleared 510(K)
- K841659DRIGALSKI LITMUS LACTOSE AGAR1Cleared 510(K)
- K841389RIM-DNASE KIT1Cleared 510(K)
- K840685PORPHYRIN TEST AGAR1Cleared 510(K)
- K841212SINGLE BIOCHEMICAL TEST1Cleared 510(K)
- K834327CIN AGAR1Cleared 510(K)
- K830397PEM-C1Cleared 510(K)
- K823000MACATE BROTH1Cleared 510(K)
- K822995ANDRADES FERMENTATION MEDIA1Cleared 510(K)
- K822999DNASE TEST AGAR W/TOLUIDINE BLUE1Cleared 510(K)
- K823001PEPTONE IRON AGAR1Cleared 510(K)
- K822996JORDANS TARTRATE AGAR1Cleared 510(K)
- K822694YEAST ASSIMILATION BROTH1Cleared 510(K)
- K821845EGG YOLK AGAR (PLATE)1Cleared 510(K)
- K821593BILE ESCULIN AZIDE BROTH1Cleared 510(K)
- K821594UREA AGAR SLANT1Cleared 510(K)
- K821606BILE ESCULIN AGAR1Cleared 510(K)
- K820839CULTURE MEDIA, SINGLE BIOCHEM. TEST1Cleared 510(K)
- K820809#2008 SIMMONS CITRATE1Cleared 510(K)
- K820149PYR BROTH1Cleared 510(K)
- K812465PHOS MICROTUBES1Cleared 510(K)
- K812468PYRR MICROTUBE1Cleared 510(K)
- K812470HIPP MICROTUBE1Cleared 510(K)
- K812469RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB1Cleared 510(K)
- K800287CEPH LACTAM DISK1Cleared 510(K)
- K791945NITRATE BROTH1Cleared 510(K)
- K791476.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)1Cleared 510(K)
- K791474SIMMONS CITRATE AGAR1Cleared 510(K)
- K790626LOMBARD-DOWELL GLUCOSE AGAR1Cleared 510(K)
- K790231DECARBOXYLASE, BUFFERED LYSINE1Cleared 510(K)
- K781506MIC-BIO-PLATE1Cleared 510(K)
- K781369MICRODILUTION ANAEROBE ID. PANEL1Cleared 510(K)
- K780907MIC-20001Cleared 510(K)
- K780533PRE-REDUCED MEDIA1Cleared 510(K)
- 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
- 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
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K874175
- 510(k) Type
- Traditional
- Applicant
- OTISVILLE BIOPHARM, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/4/1987
- Days to Decision
- 52 days