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
- K962265MLX MICROTITER PLATE LUMINOMETER1Cleared 510(K)
- K883995X-ACT UREA/TDA1Cleared 510(K)
- K883996X-ACT LDC/IND1Cleared 510(K)
- K880133MIL MEDIUM1Cleared 510(K)
- K880116MRVP BROTH1Cleared 510(K)
- K874537KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR1Cleared 510(K)
- K871096CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES1Cleared 510(K)
- K864674MICRODILUTION IDENTIFICATION PANELS1Cleared 510(K)
- K862393BIOTIS LITMUS MILK1Cleared 510(K)
- K860415BIOTIS SIMMON CITRATE AGAR1Cleared 510(K)
- K860412BIOTIS SIM MEDIUM1Cleared 510(K)
- K860413BIOTIS TSI1Cleared 510(K)
- K860415BIOTIS SIMMON CITRATE AGAR1Cleared 510(K)
- K860194AUSTIN ENTERIC SYSTEM1Cleared 510(K)
- K850982CTAPI - NEISSERA SCREEN1Cleared 510(K)
- K850734DIFFERENTIAL CULTURE MEDIUM1Cleared 510(K)
- K850548LYSINE IRON AGAR LIA1Cleared 510(K)
- K850551SIM MEDIUM1Cleared 510(K)
- K850546KLIGLER IRON AGAR KIA1Cleared 510(K)
- K850547MOTILITY INDOLE ORNITHINE AGAR1Cleared 510(K)
- K843768BIOTIS KLIGLER IRON AGAR1Cleared 510(K)
- K842451RIM STREP KIT1Cleared 510(K)
- K842424BIOTIS LD-PRESUMPTO QUADRANT PLATE1Cleared 510(K)
- K841204MULTIPLE BIOCHEMICAL TEST1Cleared 510(K)
- K834003MOTILITY INDOLE ORNITHINE-MEDIUM1Cleared 510(K)
- K834001KLIGLER IRON AGAR1Cleared 510(K)
- K834002LYSINE IRON AGAR1Cleared 510(K)
- K834004MYCOBIOTIC AGAR1Cleared 510(K)
- K834012SIM MEDIUM1Cleared 510(K)
- K832568INDOLE NITRATE MEDIUM1Cleared 510(K)
- K830525API 20GP1Cleared 510(K)
- K822998CHRISTENSENS CITRATE SULFIDE AGAR1Cleared 510(K)
- K823072LECITHIN LACTOSE AGAR1Cleared 510(K)
- K821592TRIPLE SUGAR IRON AGAR SLANT1Cleared 510(K)
- K820842CULTURE MEDIA, NON-SELECTIVE/DIFFER1Cleared 510(K)
- K820841CULTURE MEDIA, MULTIPLE BIOCHEMICAL1Cleared 510(K)
- K820810#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE1Cleared 510(K)
- K820214SUCROSE1Cleared 510(K)
- K812911BCYE MEDIUM1Cleared 510(K)
- K812466ONPX-INDOL MEDIUM MICROTUBES1Cleared 510(K)
- K812467PGUA-INDOL MICROTUBE1Cleared 510(K)
- K800734RAPID FERMENTATION AGAR (RFA)1Cleared 510(K)
- K792420SIM MEDIUM1Cleared 510(K)
- K792425DECARBOXYLASE MOELLER BASE WITH OR WITH-1Cleared 510(K)
- K791473TRIPLE SUGAR IRON AGAR (TSI AGAR)1Cleared 510(K)
- K791222API 20E REAGENT QC1Cleared 510(K)
- K790617CARBOHYDRATE FERMENTATION MEDIA1Cleared 510(K)
- K790230DENTRIFICATION LACTOSE AGAR1Cleared 510(K)
- K790232AGAR, MOTILITY-NITRATE1Cleared 510(K)
- K781856PLATE, LD PRESUMPTO1Cleared 510(K)
- K770989API 50 E1Cleared 510(K)
- K770746PANEL, IDENTIFICATION, STREP, MICRO-ID1Cleared 510(K)
- K770176API 3S1Cleared 510(K)
- 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
- 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
SIM MEDIUM
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K792420
- 510(k) Type
- Traditional
- Applicant
- ISLE MEDIA AND STERILE PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/31/1979
- Days to Decision
- 34 days