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
- K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T30071Cleared 510(K)
- K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT1Cleared 510(K)
- K881563TRYPTOSE PHOSPHATE BROTH1Cleared 510(K)
- K881562TRYPTOSE BLOOD AGAR BASE1Cleared 510(K)
- K881550OF BASAL MEDIUM1Cleared 510(K)
- K881522DEXTROSE AGAR1Cleared 510(K)
- K881554SKIM MILK DEHYDRATED1Cleared 510(K)
- K881548MPH AGAR1Cleared 510(K)
- K881528CASEIN PEPTONE, LOW VITAMIN1Cleared 510(K)
- K881543LETHEEN AGAR1Cleared 510(K)
- K881532BLOOD AGAR BASE W/LOW PH1Cleared 510(K)
- K881528CASEIN PEPTONE, LOW VITAMIN1Cleared 510(K)
- K881541GELATIN1Cleared 510(K)
- K881542HEART INFUSION AGAR1Cleared 510(K)
- K881543LETHEEN AGAR1Cleared 510(K)
- K881545MALT EXTRACT1Cleared 510(K)
- K881546MALT EXTRACT AGAR1Cleared 510(K)
- K881548MPH AGAR1Cleared 510(K)
- K881550OF BASAL MEDIUM1Cleared 510(K)
- K881554SKIM MILK DEHYDRATED1Cleared 510(K)
- K881557TRYPTONE1Cleared 510(K)
- K880947NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE1Cleared 510(K)
- K880142TSA W/LEC. & TWEEN. 801Cleared 510(K)
- K881115BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA1Cleared 510(K)
- K880114NUTRIENT BROTH1Cleared 510(K)
- K875259BITEK(TM) BLOOD CULTURE SYSTEM1Cleared 510(K)
- K875273BITEK(TM) BLOOD CULTURE SYSTEM1Cleared 510(K)
- K875136COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P37501Cleared 510(K)
- K874538TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T35161Cleared 510(K)
- K873257GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA.1Cleared 510(K)
- K873483TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z30201Cleared 510(K)
- K873482TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z30331Cleared 510(K)
- K873480TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z30231Cleared 510(K)
- K873328SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P32521Cleared 510(K)
- K873325SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE1Cleared 510(K)
- K873219BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T35831Cleared 510(K)
- K873222BRAIN HEART INFUSION BROTH W/X AND V - #T45401Cleared 510(K)
- K873221BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P34091Cleared 510(K)
- K873220BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T30031Cleared 510(K)
- K873217BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T30061Cleared 510(K)
- K873243BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T32861Cleared 510(K)
- K873235BRAIN HEART INFUSION AGAR POUR TUBE, - #T30041Cleared 510(K)
- K873236BRAIN HEART INFUSION AGAR SLANT TUBE, - #T29041Cleared 510(K)
- K873232BRAIN HEART INFUSION AGAR - BHIA PRODUCT #P33021Cleared 510(K)
- K873062TRYPTIC SOY AGAR POUR TUBE - PRODUCT #T91721Cleared 510(K)
- K873053TRYPTIC SOY AGAR (TSA - PRODUCT #P2802)1Cleared 510(K)
- K873057TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8903 7ML1Cleared 510(K)
- K873059TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8765 11ML1Cleared 510(K)
- K872681IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K872679IAFP T.S.A. (TRYPTIC SOY AGAR)1Cleared 510(K)
- K872677IAFP B.H.I. AGAR1Cleared 510(K)
- K872668IAFP T.S.A. W/10% SHEEP BLOOD1Cleared 510(K)
- K872667IAFP BRAIN HEART INFUSION BROTH1Cleared 510(K)
- K870639BHI WITH SHEEP BLOOD (5%)1Cleared 510(K)
- K871089ANAEROBIC BLOOD AGAR (CDC FORMULATION)1Cleared 510(K)
- K871098TRYPTIC SOY AGAR1Cleared 510(K)
- K870798T7202 THIO W/O IND W/DEXTROSE1Cleared 510(K)
- K870799T2500 FLUID THIO1Cleared 510(K)
- K870800T2570 THIO W/O IND W/O DEXTROSE1Cleared 510(K)
- K864255TRYPTICASE SOY BROTH1Cleared 510(K)
- K864240COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD1Cleared 510(K)
- K864254THIOGLYCOLLATE BROTH1Cleared 510(K)
- K870592T4013 TSB 5ML1Cleared 510(K)
- K870595T4012 TSB 2ML1Cleared 510(K)
- K870593T9000 TSB 10ML1Cleared 510(K)
- K870133HY PBC FLASK1Cleared 510(K)
- K862946OXOID SIGNAL BLOOD CULTURE SYSTEM1Cleared 510(K)
- K861480CHARCOAL AGAR BASE1Cleared 510(K)
- K860403BIOTIS TSA WITH 5% RABBIT BLOOD1Cleared 510(K)
- K860401BIOTIS TRYPTIC SOY AGAR SLANTS1Cleared 510(K)
- K860399BIOTIS TODD HEWITT BROTH1Cleared 510(K)
- K860397BIOTIS TSA1Cleared 510(K)
- K860408BIOTIS NUTRIENT AGAR1Cleared 510(K)
- K860409BIOTIS COLUMBIA SHEEP BLOOD AGAR1Cleared 510(K)
- K860411BIOTIS BHI AGAR1Cleared 510(K)
- K854455CDC ANAEROBE BLOOD AGAR1Cleared 510(K)
- K853690COLUMBIZ BLOOD AGAR1Cleared 510(K)
- K851598THIOGLYCOLLATE WITHOUT INDICATOR1Cleared 510(K)
- K851601TRYPTIC SOY BROTH1Cleared 510(K)
- K851250SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH1Cleared 510(K)
- K850998URI-KIT1Cleared 510(K)
- K850848BRAIN HEART INFUSION AGAR1Cleared 510(K)
- K850847THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN1Cleared 510(K)
- K850842BRAIN HEART INFUSION BROTH1Cleared 510(K)
- K850733MULTIPURPOSE CULTURE MEDIUM1Cleared 510(K)
- K850658CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE1Cleared 510(K)
- K850549TODD HEWITT BROTH1Cleared 510(K)
- K850558CORN MEAL AGAR W/POLYSORBATE 80, CORN MEAL W/POLYS1Cleared 510(K)
- K844541TRYPTIC SOY BROTH1Cleared 510(K)
- K844538COOKED MEAT MEDIUM1Cleared 510(K)
- K844537FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR1Cleared 510(K)
- K844536THIOGLYCOLLATE W/O INDICATOR1Cleared 510(K)
- K844529BRAIN HEART INFUSION BROTH1Cleared 510(K)
- K844528NUTRIENT BROTH1Cleared 510(K)
- K844526THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR1Cleared 510(K)
- K843764BIOTIS SCHAEDLER AGAR & BROTH1Cleared 510(K)
- K841662MAXIMUM RECOVERY DILUENT1Cleared 510(K)
- K842036BIPHASIC BLOOD CULTURE BOTTLE1Cleared 510(K)
- K841835MULTIPURPOSE CULTURE MEDIUM1Cleared 510(K)
- K841303CAMPYLOBACTER THIOGLYCOLLATE MED1Cleared 510(K)
- K841203GENERAL NUTRIENT BROTH1Cleared 510(K)
- K841143COLUMBIA AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K841144CHOCOLATE AGAR W/COFACTOR1Cleared 510(K)
- K841130TRYPTICASE SOY AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K840518SABOURAUD AGAR SLANTS1Cleared 510(K)
- K840077THIOGLYCOLLATE MEDIUM TUBE1Cleared 510(K)
- K840075TRYPTICASE SOY BROTH TUBE1Cleared 510(K)
- K840069ANAEROBIC AGAR PLATE1Cleared 510(K)
- K840072BORDET GENGOU AGAR PLATE1Cleared 510(K)
- K834324TSA1Cleared 510(K)
- K834427THIOGEL MEDIUM TUBE1Cleared 510(K)
- K834426LOEFFLER MEDIUM TUBE1Cleared 510(K)
- K834425CTA MEDIUM TUBE1Cleared 510(K)
- K834418CDC ANAEROBE BLOOD AGAR PLATE1Cleared 510(K)
- K834321THIO W/SUPPLEMENT1Cleared 510(K)
- K834319BHI AGAR1Cleared 510(K)
- K834322EMMON 3 SABDEX1Cleared 510(K)
- K834323POTATO DEXTROSE AGAR1Cleared 510(K)
- K834206EUGONIC AGAR1Cleared 510(K)
- K834006BRUCELLA MEDIA1Cleared 510(K)
- K834014POTATO DEXTROSE AGAR1Cleared 510(K)
- K834016GN BROTH1Cleared 510(K)
- K833507PREPARED TRYPTIC SOY AGAR 100 MM PLATE1Cleared 510(K)
- K833299BRUCELLA AGAR MODIFIED1Cleared 510(K)
- K833296SABOURAUD DEXTROSE AGAR, EMMONS1Cleared 510(K)
- K833209ACIDICASE-BB11Cleared 510(K)
- K833217STANDARD METHOD BROTH1Cleared 510(K)
- K833215BEEF EXTRACT1Cleared 510(K)
- K832534SHEEP BLOOD AGAR PLATE1Cleared 510(K)
- K832611TRYPTIC SOY AGAR1Cleared 510(K)
- K831671MODIFIED SOYBEAN CASEIN DIGEST BROTH1Cleared 510(K)
- K830805KNAI SODIUM POTASSIUM ANALYZER1Cleared 510(K)
- K830130MINIATURE ION SELECTIVE ELECTRODES1Cleared 510(K)
- K830068NUTRIENT AGAR1Cleared 510(K)
- K830063CONTACT PLATE LECITHIN & POLYSORBATE 801Cleared 510(K)
- K830075COLUMBIA SHEEP BLOOD AGAR 5%1Cleared 510(K)
- K830077BRAIN HEART INFUSION AGAR1Cleared 510(K)
- K821604SABOURAUD'S DEXTROSE (SABDEX)1Cleared 510(K)
- K820791#4005 TSA SLANT-TUBED MEDIA1Cleared 510(K)
- K820559ANAEROBE BLOOD AGAR1Cleared 510(K)
- K820551BRUCELLA AGAR W/15% SHEEP BLOOD1Cleared 510(K)
- K820549THIOGLYCOLLATE W/INDICATOR1Cleared 510(K)
- K820556TRYPTIC SOY AGAR1Cleared 510(K)
- K813232COOKED MEAT MEDIUM1Cleared 510(K)
- K812730SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE1Cleared 510(K)
- K812798MOTILITY GI MEDIUM1Cleared 510(K)
- K812797SCHAEDLER AGARS1Cleared 510(K)
- K812795ANAEROBIC BLOOD AGAR1Cleared 510(K)
- K812729SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE1Cleared 510(K)
- K812732SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE1Cleared 510(K)
- K811734BRUCELLA BROTH1Cleared 510(K)
- K811735CTA MEDIUM1Cleared 510(K)
- K811729COLUMBIA1Cleared 510(K)
- K811731DEXTROSE BROTH1Cleared 510(K)
- K811651TRYPTICASE1Cleared 510(K)
- K811654BRAIN HEART INFUSION AGAR1Cleared 510(K)
- K811640MEDICASE SOY AGAR1Cleared 510(K)
- K811641COLUMBIA AGAR BASE1Cleared 510(K)
- K811612TRYPTIC SOY AGAR1Cleared 510(K)
- K811606FLUID THIOCLYCOLLATE MEDIUM1Cleared 510(K)
- K811515THIOGLYCOLLATE MED. W/OUT INDICATOR1Cleared 510(K)
- K811475TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOOD1Cleared 510(K)
- K811359AGAR, BACTERIOLOGICAL1Cleared 510(K)
- K811353BRAIN HEART INFUSION W/O DEXTROSE1Cleared 510(K)
- K811340THIOGLYCOLLATE MEDIUM W/OUT INDICATOR1Cleared 510(K)
- K811321STANDARD METHODS AGAR1Cleared 510(K)
- K811135COLUMBIA BLOOD AGAR BASE1Cleared 510(K)
- K811047FLUID THIOGLYCOLLATE MEDIUM1Cleared 510(K)
- K811055BLOOD AGAR BASE PH 7.41Cleared 510(K)
- K811052TRYPTIC SOY AGAR W/LECITHIN & TWEEN 801Cleared 510(K)
- K811051TRYPTIC SOY AGAR1Cleared 510(K)
- K811050TRYPTIC SOY BROTH1Cleared 510(K)
- K810553PEDIATRIC BLOOD CULTURE BOTTLES1Cleared 510(K)
- K803025CDC ANAEROBE BLOOD AGAR1Cleared 510(K)
- K803023ENRICHED THIOGLYCOLLATE MEDIUM1Cleared 510(K)
- K802892CULTURE MEDIA FOR IN VITRO DIAG. USE1Cleared 510(K)
- K802415BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT1Cleared 510(K)
- K802397ANAEROBE BLOOD AGAR1Cleared 510(K)
- K801980SPOR-TEST CULTURE MEDIA1Cleared 510(K)
- K801943BRAIN HEART INFUSION MICROBIOLOGICAL1Cleared 510(K)
- K800986TRYPTICASE SOY AGAR W5% SHEEP BLOOD1Cleared 510(K)
- K800981CHOCOLATE AGAR W/ENRICHMENTS1Cleared 510(K)
- K800985THIOGLYCOLLATE MED. W/O INDICATOR1Cleared 510(K)
- K792423TODD HEWITT BROTH1Cleared 510(K)
- K792594TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.1Cleared 510(K)
- K792543TRYPTOSE BLOOD AGAR BASE & TRYPTOSE1Cleared 510(K)
- K792276BRAIN HEART INFUSION W/PABA, O.1%,1Cleared 510(K)
- K791943NUTRIENT AGAR1Cleared 510(K)
- K791698CDC ANAEROBIC SHEEP BLOOD AGAR (BA)1Cleared 510(K)
- K791630BRAIN HEART INFUSION AGAR1Cleared 510(K)
- K791631SABOURAUD DEXTROSE AGAR1Cleared 510(K)
- K791628BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD1Cleared 510(K)
- K791620TRYPTIC SOY AGAR 5% SHEEP BLOOD1Cleared 510(K)
- K791622COLUMBIA AGAR WITH5% SHEEP1Cleared 510(K)
- K791607BETA-CELL1Cleared 510(K)
- K791553CHOCOLATE AGAR1Cleared 510(K)
- K791562ANAEROBIC BRUCELLA BLOOD AGAR1Cleared 510(K)
- K791544TRYPTIC SOY AGAR WITH SHEEP BLOOD1Cleared 510(K)
- K791542THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR1Cleared 510(K)
- K791517COLUMBIA BLOOD AGAR1Cleared 510(K)
- K791516TRYPTIC SOY AGAR1Cleared 510(K)
- K790622CHOPPED MEAT AGAR1Cleared 510(K)
- K790621CHOPPED MEAT GLUCOSE MEDIUM1Cleared 510(K)
- K790497BACTERIOLOGICAL CULTURE MEDIA1Cleared 510(K)
- K790459CEMENT DISPENSER CEMENT MIXER1Cleared 510(K)
- K790375TRYPTIC SOY AGAR W/ 5% HORSE BLOOD1Cleared 510(K)
- K781604CDC ANAEROBE BLOOD AGAR1Cleared 510(K)
- K760764YEAST ASSIMILATION AGAR1Cleared 510(K)
- K760459MUELLER HINTON AGAR W/HEMOGLOBIN1Cleared 510(K)
- 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
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K851250
- 510(k) Type
- Traditional
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/22/1985
- Days to Decision
- 26 days