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
- K881560UREA BROTH1Cleared 510(K)
- K881559UREA AGAR BASE1Cleared 510(K)
- K881540FLO AGAR1Cleared 510(K)
- K881551PHENOL RED BROTH BASE1Cleared 510(K)
- K881553RUSSELL DOUBLE SUGAR AGAR1Cleared 510(K)
- K881486DNASE TEST AGAR1Cleared 510(K)
- K880121MOELLERS DECARBOXYLASE, BASE1Cleared 510(K)
- K880117OF MEDIUM BASE1Cleared 510(K)
- K873270ACTINOMYCETE DIFFERENTIAL MEDIA1Cleared 510(K)
- K873263MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA1Cleared 510(K)
- K873411SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T30841Cleared 510(K)
- K873704MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T30531Cleared 510(K)
- K873703LYSINE IRON AGAR (LIA) PRODUCT #T30461Cleared 510(K)
- K872670IAFP MAC CONKEY AGAR1Cleared 510(K)
- K872020MUCATE AGAR, SLANTS AND MUCATE BROTH1Cleared 510(K)
- K871855SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM1Cleared 510(K)
- K871701ARYLSULFATASE BROTH1Cleared 510(K)
- K870651BIGGY AGAR1Cleared 510(K)
- K870636HEMOPHILUS ID QUAD PLATE1Cleared 510(K)
- K871095CLED AGAR1Cleared 510(K)
- K864239CLED AGAR WITH ANDRADES INDICATOR1Cleared 510(K)
- K864454THERMOSTABLE NUCLEASE TEST AGAR1Cleared 510(K)
- K864205THERMONUCLEASE AGAR W/TOLUIDINE BLUE1Cleared 510(K)
- K864100TRYCOPHYTON AGARS1Cleared 510(K)
- K863600MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM1Cleared 510(K)
- K863599STARCH AGAR W/BROM CRESOL PURPLE1Cleared 510(K)
- K863573BIRD SEED AGAR1Cleared 510(K)
- K863572XANTHINE/TYROSINE/CASEIN AGAR1Cleared 510(K)
- K863523TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR1Cleared 510(K)
- K862387BIOTIS HAEMOPHILUS IDENTIFICATION QUAD1Cleared 510(K)
- K862395BIOTIS DECARBOXYLASE MEDIA, BASE1Cleared 510(K)
- K860750PSEUDOMONAS AGAR P (MEDIUM A)1Cleared 510(K)
- K853618APL SIM MEDIUM1Cleared 510(K)
- K853610APL MOTILITY INDOLE ORNITHINE AGAR1Cleared 510(K)
- K853619APL TRIPLE SUGAR IRON AGAR1Cleared 510(K)
- K853612APL DNASE TEST AGAR1Cleared 510(K)
- K853614APL FLUID THIOGLYCOLLATE MEDIUM1Cleared 510(K)
- K853615APL BILE ESCULIN/AZIDE AGAR1Cleared 510(K)
- K853616APL CHLAMYDOSPORE AGAR1Cleared 510(K)
- K853613APL GN BROTH1Cleared 510(K)
- K853336DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR1Cleared 510(K)
- K852578CLED AGAR1Cleared 510(K)
- K852064DRI-FORM PSEUDOMONAS AGAR F1Cleared 510(K)
- K851595SIMMONS CITRATE AGAR1Cleared 510(K)
- K851597TRIPLE SUGAR IRON AGAR1Cleared 510(K)
- K851596SIM MEDIUM1Cleared 510(K)
- K851576BIGGY AGAR NICKERSONS MEDIUM1Cleared 510(K)
- K851602UREA AGAR1Cleared 510(K)
- K851344OXIDATIVE FORMENTIVE MEDIUM1Cleared 510(K)
- K851343BROM CRESOL PURPLE STARCH1Cleared 510(K)
- K851346PHENYLALANINE AGAR1Cleared 510(K)
- K851345PURPLE BROTH1Cleared 510(K)
- K850719DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR1Cleared 510(K)
- K850721KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E1Cleared 510(K)
- K850844V AGAR1Cleared 510(K)
- K850718CORN MEAL AGAR1Cleared 510(K)
- K844548UREA AGAR1Cleared 510(K)
- K844514DTM AGAR1Cleared 510(K)
- K844516STARCH HYDROLYSIS AGAR W/INDICATOR1Cleared 510(K)
- K844532SIMMONS CITRATE AGAR1Cleared 510(K)
- K844522SF BROTH1Cleared 510(K)
- K844521SIM MEDIUM1Cleared 510(K)
- K844520KLIGER IRON AGAR1Cleared 510(K)
- K844519HAEMOPHILUS I.D. QUAD1Cleared 510(K)
- K844513V AGAR1Cleared 510(K)
- K844531TRIPLE SUGAR IRON1Cleared 510(K)
- K843771BIOTIS SEVEN H 11 AGAR1Cleared 510(K)
- K843769BIOTIS LOWENSTEIN-JENSEN MEDIA1Cleared 510(K)
- K842850TRIPLE SUGAR IRON1Cleared 510(K)
- K842851ORNITHINE INDOLE MOTILITY1Cleared 510(K)
- K841843DIFFERENTIAL CULTURE MED. LEVINE EMB1Cleared 510(K)
- K841206NON-SELECTIVE & DIFFERENTIAL1Cleared 510(K)
- K840071DNASE AGAR W/TOLUDINE BLUE PLATE1Cleared 510(K)
- K840073ESCULIN AGAR PLATE1Cleared 510(K)
- K840068BILE ESCULIN AGAR PLATE1Cleared 510(K)
- K840070EGG YOLK AGAR PLATE1Cleared 510(K)
- K834509ACETAMIDE AGAR SLANTS1Cleared 510(K)
- K834204MIDDLEBROOK & COHN 7H11 AGAR BASE1Cleared 510(K)
- K834205MIDDLEBROOK & COHN 7H10 AGAR BASE1Cleared 510(K)
- K834009SIMMONS CITRATE AGAR1Cleared 510(K)
- K833291JH PEPTONE AGAR1Cleared 510(K)
- K833201SIMMONS CITRATE AGAR1Cleared 510(K)
- K833206TECH AGAR1Cleared 510(K)
- K833208MR-VP BROTH1Cleared 510(K)
- K833213KLIGLER IRON AGAR1Cleared 510(K)
- K833216MOTILITY TEST MEDIUM1Cleared 510(K)
- K833202MOELLER DECARBOXYLASE BROTH1Cleared 510(K)
- K832532AGAR PLATE XLD1Cleared 510(K)
- K832574BTB LACTOSE AGAR1Cleared 510(K)
- K832573C.L.E.D. MEDIUM1Cleared 510(K)
- K832616MACCONKEY AGAR MEDIA1Cleared 510(K)
- K831827EGG YOLK AGAR1Cleared 510(K)
- K830073LEVINE EMB AGAR1Cleared 510(K)
- K830020ACETAMIDE AGAR1Cleared 510(K)
- K823311COLUMBIA V AGAR W/5% HUMAN BLOOD1Cleared 510(K)
- K823070ACETAMIDE AGAR SLANT1Cleared 510(K)
- K823071RICE EXTRACT AGAR1Cleared 510(K)
- K823091H BROTH1Cleared 510(K)
- K822702V AGAR1Cleared 510(K)
- K822377HAEMOPHILUS ID PLATE1Cleared 510(K)
- K821659RESPIRACULT-STREP DEEP BED CULTURE PAD1Cleared 510(K)
- K821595MOTILITY TEST MEDIUM1Cleared 510(K)
- K821609VAGAR1Cleared 510(K)
- K821418TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K821417TRYPTIC SOY AGAR W/10% SHEEP BLOOD1Cleared 510(K)
- K821425COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K821424TRYPTIC SOY AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K821302#50003 QUAD DIAGNOSTIC SYSTEM1Cleared 510(K)
- K811852REDUCT-ASE TUBES1Cleared 510(K)
- K811597UREA AGAR SLANT1Cleared 510(K)
- K811335THIOGLYCOLLATE GELATIN MEDIUM1Cleared 510(K)
- K811330SIM MEDIUM1Cleared 510(K)
- K811130LACTOSE BROTH1Cleared 510(K)
- K811044TRIPLE SUGAR IRON AGAR1Cleared 510(K)
- K802995TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL1Cleared 510(K)
- K802994TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL1Cleared 510(K)
- K801817MICROBIOLOGY CULTURE MEDIA, C.L.E.D.1Cleared 510(K)
- K801847TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA1Cleared 510(K)
- K800978XYLOSE LYSINE DESOXYCHOLATE AGAR1Cleared 510(K)
- K800984EOSIN METHYLENE BLUE AGAR, LEVINE1Cleared 510(K)
- K800982SALMONELLA SHIGELLA AGAR1Cleared 510(K)
- K800818CHLAMYDOSPORE AGAR1Cleared 510(K)
- K792542VOGEL-JOHNSON AGAR1Cleared 510(K)
- K792421DECARBOXYLASE BROTH BASE WITH OR WITH-1Cleared 510(K)
- K792544LYSINE IRON AGAR1Cleared 510(K)
- K792286MR-VP MEDIUM1Cleared 510(K)
- K792288TRYPTONE BROTH (TRYPTOPHANE BROTH)1Cleared 510(K)
- K791941PHENOL RED BROTH1Cleared 510(K)
- K791946OF BASAL MEDIUM1Cleared 510(K)
- K791944NITRATE AGAR1Cleared 510(K)
- K791939PHENOL RED AGAR1Cleared 510(K)
- K791817MIO MEDIUM (MOTILITY INDOLE ORNITHINE)1Cleared 510(K)
- K791814BILE ESCULIN AGAR1Cleared 510(K)
- K791813DNASE TEST AGAR W/METHYL GREEN1Cleared 510(K)
- K791671DNASE TEST AGAR1Cleared 510(K)
- K791556MACCONKEY AGAR (PLATE)1Cleared 510(K)
- K791594CYSTINE TRYPTIC AGAR1Cleared 510(K)
- K791591MOTILITY TEST MEDIUM1Cleared 510(K)
- K791590PHENYLALANINE AGAR1Cleared 510(K)
- K790627LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID1Cleared 510(K)
- K790623LOMBARD-DOWELL MILK AGAR1Cleared 510(K)
- K790618LOMBARD-DOWELL STARCH AGAR1Cleared 510(K)
- K790229VAGINALIS, HAEMOPHILUS1Cleared 510(K)
- K780615BLOOD CULTURE MEDIA1Cleared 510(K)
- K771936MICROBIOLOGICAL CULTURE MEDIUM1Cleared 510(K)
- K771686UREAPLASMA DIFFERENTIAL BASAL AGAR MED.1Cleared 510(K)
- 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
UREA AGAR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K844548
- 510(k) Type
- Traditional
- Applicant
- BIO MERIEUX, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/16/1985
- Days to Decision
- 56 days