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
- K070691BBL CHROMAGAR 01571Cleared 510(K)
- K974428DIPSTREAK1Cleared 510(K)
- K891593LISTERIA SELECTIVE ENRICHMENT MEDIUM1Cleared 510(K)
- K890199DENTOCULT SM-STRIP MUTANS1Cleared 510(K)
- K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P33261Cleared 510(K)
- K881577MODIFIED SELECTIVE STREPTOCOCCUS AGAR1Cleared 510(K)
- K881576SELENITE BROTH1Cleared 510(K)
- K881575SELECTIVE STREPTOCOCCUS AGAR1Cleared 510(K)
- K881572XL AGAR BASE1Cleared 510(K)
- K881556TRICHOMONAS BROTH1Cleared 510(K)
- K881555TINSDALE AGAR BASE1Cleared 510(K)
- K880125LOWENSTEIN-JENSEN, SELECTIVE1Cleared 510(K)
- K880132DERMATOPHYTE TEST MEDIUM1Cleared 510(K)
- K880108CORN MEAL W/POLYSORBATE 801Cleared 510(K)
- K880130ATS MEDIA1Cleared 510(K)
- K874344QUAD PLATE (4 DIFFERENT MEDIA)1Cleared 510(K)
- K873258STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA1Cleared 510(K)
- K873259SPECIALTY MEDIA1Cleared 510(K)
- K873260CORYNEBACTERIA ISOLATION MEDIA1Cleared 510(K)
- K873269MYCOLOGICAL MEDIA1Cleared 510(K)
- K873262DIFFERENTIAL MEDIA1Cleared 510(K)
- K873264MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS1Cleared 510(K)
- K873265MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION1Cleared 510(K)
- K873261ENTERIC ISOLATION MEDIA1Cleared 510(K)
- K873481HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z30161Cleared 510(K)
- K873329HEKTOEN ENTERIC (HE) AGAR PRODUCT #P33301Cleared 510(K)
- K873223MACCONKEY AGAR - PRODUCT #P16061Cleared 510(K)
- K873225EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P13091Cleared 510(K)
- K873226XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P36011Cleared 510(K)
- K873227MANNITOL SALT AGAR (MSA) PRODUCT #P17061Cleared 510(K)
- K873228LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P15071Cleared 510(K)
- K872301DENTOCULT-SM CULTURE-PADDLE1Cleared 510(K)
- K873055MACCONKEY AGAR - PRODUCT #P16061Cleared 510(K)
- K872683IAFP BILE ESCULIN AGAR1Cleared 510(K)
- K872682IAFP S.S. AGAR1Cleared 510(K)
- K872675IAFP MANNITOL NACL1Cleared 510(K)
- K872672IAFP BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K872669IAFP X.L.D. AGAR1Cleared 510(K)
- K872956SORBITOL MACCONKEY AGAR NO. 3 CM 8131Cleared 510(K)
- K872188MACCONKEY W/SORBITOL1Cleared 510(K)
- K872058ORICULT-N CULTURE-PADDLE1Cleared 510(K)
- K870640CETRIMIDE SELECTIVE AGAR1Cleared 510(K)
- K870648STAPHYLOCOCCUS 110 AGAR1Cleared 510(K)
- K870644BRILLIANT GREEN AGAR1Cleared 510(K)
- K870643POTATO DEXTROSE AGAR1Cleared 510(K)
- K870638BACTEROIDES BILE ESCULIN AGAR1Cleared 510(K)
- K871088ANAEROBIC LKV BLOOD AGAR1Cleared 510(K)
- K871094BRILLIANT GREEN AGAR1Cleared 510(K)
- K864243MACCONKEY AGAR1Cleared 510(K)
- K864242HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K870502CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS1Cleared 510(K)
- K870341P1012 BE AGAR1Cleared 510(K)
- K870339P4802 BEA1Cleared 510(K)
- K870340Z2017, BEA/CNA 5%SB BIPLATE1Cleared 510(K)
- K870057T1365 (BIRD SEED AGAR SLANT)1Cleared 510(K)
- K864764CULTURIA MACCONKEY-MUG/CLED SYSTEMS1Cleared 510(K)
- K864077CANDIDA BROM CRESOL GREEN AGAR1Cleared 510(K)
- K863519CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR1Cleared 510(K)
- K863525DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS1Cleared 510(K)
- K854672CANDI-KIT TM1Cleared 510(K)
- K862394BIOTIS MITIS SALIVARIUS1Cleared 510(K)
- K862391BIOTIS DESOXYCHOLATE AGAR1Cleared 510(K)
- K862389BIOTIS ACETAMIDE AGAR1Cleared 510(K)
- K862388BIOTIS TCBS AGAR1Cleared 510(K)
- K862425MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM1Cleared 510(K)
- K860707OFPBL1Cleared 510(K)
- K860385BIOTIS MAC-MUG1Cleared 510(K)
- K860386BIOTIS SF BROTH1Cleared 510(K)
- K860388BIOTIS KF STREPTOCOCCUS AGAR1Cleared 510(K)
- K860402BIOTIS BISMUTH SULFITE AGAR1Cleared 510(K)
- K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM1Cleared 510(K)
- K855110DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A81Cleared 510(K)
- K854452MANNITOL SALT AGAR1Cleared 510(K)
- K854450BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K854449HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K853691TERGITOL 7 AGAR1Cleared 510(K)
- K853617APL SIMMONS CITRATE AGAR1Cleared 510(K)
- K853611APL XYLOSE LYSINE DEOXYCHOLATE AGAR1Cleared 510(K)
- K853488STAPH KIT1Cleared 510(K)
- K853226APL BIGGY AGAR(NICKERSON)1Cleared 510(K)
- K853235APL HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K853234APL MACCONKEY AGAR1Cleared 510(K)
- K853232APL MANNITOL SALT AGAR1Cleared 510(K)
- K853229APL 6.5% SODIUM CHLORIDE BROTH1Cleared 510(K)
- K853228APL SALMONELLA-SHIGELLA AGAR1Cleared 510(K)
- K853225APL LEVINE EMB AGAR1Cleared 510(K)
- K852789AEROMONAS AGAR(XDCA)1Cleared 510(K)
- K852480DERM-KIT1Cleared 510(K)
- K851594SF BROTH1Cleared 510(K)
- K851577BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K851603XYLOSE LYSINE DESOXYCHOLATE AGAR1Cleared 510(K)
- K851578BILE ESCULIN AGAR1Cleared 510(K)
- K851583HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K851581DERMATOPHYTE TEST MEDIUM1Cleared 510(K)
- K851585MANNITOL SALT AGAR1Cleared 510(K)
- K851584LEVINE EMB AGAR1Cleared 510(K)
- K851586MACCONKEY AGAR1Cleared 510(K)
- K850723SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC1Cleared 510(K)
- K850720EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%1Cleared 510(K)
- K850736SELECTIVE CULTURE MEDIUM1Cleared 510(K)
- K850565BIOTIS CHOCOLATE TELLURITE1Cleared 510(K)
- K850552BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE1Cleared 510(K)
- K844930BRILLANT GREEN AGAR1Cleared 510(K)
- K844933BILE ESCULIN AGAR1Cleared 510(K)
- K844934AZIDE AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K844515VIOLET RED BILE AGAR1Cleared 510(K)
- K844535YERSINIA SELECTIVE AGAR1Cleared 510(K)
- K844195BIOTIS ANAEROBIC KBE AGAR1Cleared 510(K)
- K834420MANNITOL-SALT AGAR USP PLATE1Cleared 510(K)
- K834423S S AGAR PLATE1Cleared 510(K)
- K843763BIOTIS EMB AGAR HOLT-HARRIS1Cleared 510(K)
- K843762BIOTIS EMB-LEVINE AGAR1Cleared 510(K)
- K843761BIOTIS BIGGY AGAR & BIGGY SLANT1Cleared 510(K)
- K843767BIOTIS UREA AGAR1Cleared 510(K)
- K843492NEOMYCIN BLOOD AGAR1Cleared 510(K)
- K843194V AGAR SELECTIVE DEEPS1Cleared 510(K)
- K843193STREP SELECTIVE II1Cleared 510(K)
- K843066BIOTIS CIN AGAR PLATES1Cleared 510(K)
- K842101COBA AGAR1Cleared 510(K)
- K842100MACCONKEY AGAR, PLUS1Cleared 510(K)
- K841747MANNITOL SALT AGAR1Cleared 510(K)
- K841753MACCONKEY AGAR1Cleared 510(K)
- K841752XYLOSE-LYSINE DESOXYCHOLATE AGAR1Cleared 510(K)
- K841751LEVINE EOSIN METHYLENE BLUE AGAR1Cleared 510(K)
- K841842DIFFERENTIAL CULTURE MED. MACCONKEY AGAR1Cleared 510(K)
- K841844DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR1Cleared 510(K)
- K841841DIFFERENTIAL CULTURE MED. MANNITOL SALT1Cleared 510(K)
- K841745HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K841304HAEMOPHILUS ID QUAD-PLATE1Cleared 510(K)
- K841207NON-SELECTIVE & NON-DIFFERENTIAL1Cleared 510(K)
- K841209SELECTIVE AND DIFFERENTIAL1Cleared 510(K)
- K840338HAEMOPHILUS I.D. II TRIPLATE1Cleared 510(K)
- K841218CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR1Cleared 510(K)
- K841142LEVINE EOSIN METHYLENE BLUE AGAR1Cleared 510(K)
- K841222BACTEROIDES BILE ESCULIN GAR1Cleared 510(K)
- K841134MANNITOL SALT AGAR1Cleared 510(K)
- K841141MACCONKEY AGAR1Cleared 510(K)
- K841132EILE-ESCULIN AZIDE AGAR1Cleared 510(K)
- K841131XYLOSE LYSINE DESOXYCHOLATE AGAR1Cleared 510(K)
- K841129HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K840889CLOSTRIDIUM DIFFICILE AGAR DEEP &1Cleared 510(K)
- K840615YERSINIA SUPPLEMENT1Cleared 510(K)
- K840160B-STREP-TECT-II1Cleared 510(K)
- K840294GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K840190MACCONKEY AGAR W/TWEEN 80 & AMPICIL1Cleared 510(K)
- K834320TCBS1Cleared 510(K)
- K834019BIGGY AGAR NICKERSON MEDIUM1Cleared 510(K)
- K833508PREPARED MACCONKEY AGAR1Cleared 510(K)
- K833301FEELEY-GORMAN AGAR1Cleared 510(K)
- K833254STREPTOCOCCUS ID TRIPLATE SYSTEM1Cleared 510(K)
- K833204DEOXYCHOLATE CITRATE AGAR1Cleared 510(K)
- K833219STAPHYLOCOCCUS AGAR 101Cleared 510(K)
- K833212MAC CONKEY AGAR WITHOUT CRYSTAL VIOLET1Cleared 510(K)
- K833205YERSINIA SELECTIVE AGAR1Cleared 510(K)
- K833203DEOXYCHOLATE LACTOSE AGAR1Cleared 510(K)
- K832523TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE1Cleared 510(K)
- K832535HEKTOEN ENTERIC AGAR PLATE1Cleared 510(K)
- K832524BAIRD PARKER AGAR PLATE1Cleared 510(K)
- K832955BACTEROIDES BILE ESCULIN AGAR1Cleared 510(K)
- K832954V AGAR1Cleared 510(K)
- K832863STREP ID QUAD1Cleared 510(K)
- K832572BILE ESCULIN AGAR1Cleared 510(K)
- K832571BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K832617XYLOSE LYSINE DEOXYCHOLATE1Cleared 510(K)
- K832618BLUE AGAR1Cleared 510(K)
- K832365TCBS AGAR1Cleared 510(K)
- K830251CAMPY BLOOD AGAR PLATE1Cleared 510(K)
- K830082BIGGY AGAR1Cleared 510(K)
- K830065SALMONELLA-SHIGELLA AGAR1Cleared 510(K)
- K830064XLD AGAR1Cleared 510(K)
- K830071MACCONKEY AGAR1Cleared 510(K)
- K830070MANNITOL SALT AGAR1Cleared 510(K)
- K830072HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K830079BISMUTH SULFITE AGAR1Cleared 510(K)
- K823306HEMOPHILUS QUAD 10 PLATE1Cleared 510(K)
- K823310STREPTOCOCCUS SELECTIVE AGAR1Cleared 510(K)
- K823307CAMPYLOBACTER SELECTIVE AGAR1Cleared 510(K)
- K823122LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM1Cleared 510(K)
- K822737MYCOTRIUM-RS1Cleared 510(K)
- K822736MYCOTRIUM-GU1Cleared 510(K)
- K822997STREP SELECTIVE AGAR1Cleared 510(K)
- K822855YERSINIA ISOLATION MEDIUM1Cleared 510(K)
- K821608CNA/VAGINALIS AGAR1Cleared 510(K)
- K821605XYLOSE LYSINE DEOXYCHOLATE AGAR1Cleared 510(K)
- K821775TERGITOL 7 AGAR WITH TTC1Cleared 510(K)
- K821300#2010 CAMPHYLOBACTER AGAR1Cleared 510(K)
- K821431XLD AGAR1Cleared 510(K)
- K821427MANNITOL SALT AGAR1Cleared 510(K)
- K821426STAPHYLOCOCCUS MEDIUM 11001Cleared 510(K)
- K821423MACCONKEY AGAR1Cleared 510(K)
- K821422SS AGAR1Cleared 510(K)
- K821421HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K821420EMB AGAR1Cleared 510(K)
- K821419EMB AGAR1Cleared 510(K)
- K821301#50002 QUAD DIAGNOSTIC SYSTEM1Cleared 510(K)
- K821108BI PLATE-XLD/HEKTOEN #300121Cleared 510(K)
- K820844CULTURE MEDIA, SELECTIVE & DIFFERENTIAL1Cleared 510(K)
- K820800#2006 SALMONELLA SHIGELLA AGAR1Cleared 510(K)
- K820802#2009 BIGGY AGAR1Cleared 510(K)
- K820798#2001 HEKTOEN1Cleared 510(K)
- K820797#50001 QUADE DIAGNOSTIC SYSTEM1Cleared 510(K)
- K820801#2007 XLD1Cleared 510(K)
- K820553BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K820552EOSIN METHYLENE BLUE AGAR1Cleared 510(K)
- K812731SEPTI-CHECK BLOOD CULTURE SLIDE1Cleared 510(K)
- K812187SMITH'S SYSTEMIC FUNGAL MEDIUM1Cleared 510(K)
- K811648ENDO AGAR1Cleared 510(K)
- K811642EOSIN METHYLENE BLUE AGAR (LEVINE)1Cleared 510(K)
- K811643MACCONKEY AGAR1Cleared 510(K)
- K811644HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K811647SALMONELLA-SHIGELLA AGAR1Cleared 510(K)
- K811604XYLOSE LYSINE DEOXYCHOLATE AGAR1Cleared 510(K)
- K811598DNASE AGAR MEDIA1Cleared 510(K)
- K811599EOSIN METHYLENE BLUE AGAR1Cleared 510(K)
- K811600BILE ESCULIN MEDIA1Cleared 510(K)
- K811603SALMONELLA SHIGELLA AGAR1Cleared 510(K)
- K811605HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K811609MANNITOL SALT AGAR1Cleared 510(K)
- K811610EOSIN METHYLENE BLUE AGAR (LEVINE)1Cleared 510(K)
- K811611MACCONKEY AGAR1Cleared 510(K)
- K811514BACILLUS CEREUS SELECTIVE(AGAR&SUPP)1Cleared 510(K)
- K811474TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB1Cleared 510(K)
- K811477MACCONKEY AGAR1Cleared 510(K)
- K811478EMB AGAR, LEVINE1Cleared 510(K)
- K811422STREP-ID PLATE1Cleared 510(K)
- K811420MINERALS MODIFIED MED. BASE & SOD. GLUT.1Cleared 510(K)
- K811355LYSINE IRON AGAR1Cleared 510(K)
- K811362TCBS AGAR1Cleared 510(K)
- K811332BRAIN HEART CC AGAR1Cleared 510(K)
- K811338VIOLET RED BILE AGAR1Cleared 510(K)
- K811334MYCOSEL1Cleared 510(K)
- K811331SF BROTH1Cleared 510(K)
- K811327SALMONELLA SHIGELLA AGAR1Cleared 510(K)
- K811324PHENYLETHANOL AGAR1Cleared 510(K)
- K811131HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K811134ACU-DESOXYCHOLATE AGAR1Cleared 510(K)
- K811133EOSIN-METHYLENE BLUE AGAR1Cleared 510(K)
- K811129LAURYL SULFATE BROTH1Cleared 510(K)
- K811048MACCONKEY AGAR1Cleared 510(K)
- K811039VOGEL & JOHNSON AGAR1Cleared 510(K)
- K811040CETRIMEDE AGAR1Cleared 510(K)
- K811041BRILLIANT GREEN AGAR1Cleared 510(K)
- K811042XLD AGAR1Cleared 510(K)
- K811043BISMUTH SULFITE AGAR1Cleared 510(K)
- K811045LEVIN EOSIN-METHYLENE BLUE AGAR1Cleared 510(K)
- K811046STERILITY TEST BROTH1Cleared 510(K)
- K811054BIGGY AGAR1Cleared 510(K)
- K811038BAIRD-PARKER AGAR1Cleared 510(K)
- K811037MANNITAL SALT AGAR1Cleared 510(K)
- K810929PERFRINGENS AGAR BASE1Cleared 510(K)
- K810933VOTEL-JOHNSON AGAR (MODIFIED)1Cleared 510(K)
- K810931SS AGAR (MODIFIED)1Cleared 510(K)
- K802947ORICULT DTM1Cleared 510(K)
- K800983MACCONKEY AGAR1Cleared 510(K)
- K800980HEXTOEN ENTERIC AGAR1Cleared 510(K)
- K800745CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)1Cleared 510(K)
- K800157BISMUTH SULFITE AGAR1Cleared 510(K)
- K792424CHOCOLATE TELLURITE AGAR1Cleared 510(K)
- K791942BILE ESCULIN AZIDE AGAR1Cleared 510(K)
- K791940UREA AGAR1Cleared 510(K)
- K791414DTM (DERMATOPHYTE TEST MEDIUM) AGAR1Cleared 510(K)
- K791786SALMONELLA SHIGELLA AGAR PLATE1Cleared 510(K)
- K791816DC AGAR (DESOXYCHOLATE CITRATE AGAR)1Cleared 510(K)
- K791787XYLOSE LYSINE DESOXYCHOLATE AGAR PLATE1Cleared 510(K)
- K791785MEKTOEN ENTERIC AGAR 100X15MM PLATE1Cleared 510(K)
- K791627MANNITOL SALT AGAR1Cleared 510(K)
- K791621MANNITOL SALT AGAR1Cleared 510(K)
- K791555LEVINE EOSIN METHYLER1Cleared 510(K)
- K791579ANAEROBIC BRUCELLA BLOOD AGAR1Cleared 510(K)
- K791563ANAEROBIC BRUCELLA LAKED BLOOD AGAR1Cleared 510(K)
- K791479ENDO AGAR1Cleared 510(K)
- K791477XLD AGAR (XYLASE LYSINE DESOXY AGAR)1Cleared 510(K)
- K791475HEKTOEN ENTERIC AGAR1Cleared 510(K)
- K791518BIGGY AGAR1Cleared 510(K)
- K791520EMB AGAR (EOSIN METHYLENE BLUE AGAR)1Cleared 510(K)
- K791519LEVINE EMB AGAR1Cleared 510(K)
- K791480SS AGAR (SALMONELLA SHIGELLA AGAR)1Cleared 510(K)
- K791482MACCONKEY MEDIA1Cleared 510(K)
- K791472PHENYLETHANOL AGAG (PEA)1Cleared 510(K)
- K790624LOMBARD-DOWELL BROTH MEDIUM W/LACTATE1Cleared 510(K)
- K790628LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR1Cleared 510(K)
- K790469STREP BLOOD AGAR-5% SHEEP BLOOD1Cleared 510(K)
- K790119C/N SCREEN1Cleared 510(K)
- K780704COLUMBIA AGAR WITH 5% RABBIT BLOOD1Cleared 510(K)
- K771647JEMBEC-CVSB PLATE1Cleared 510(K)
- 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-CHECK BLOOD CULTURE SLIDE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K812731
- 510(k) Type
- Traditional
- Applicant
- HOFFMANN-LA ROCHE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/19/1981
- Days to Decision
- 21 days