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
- 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
- K150031hemoFISH Masterpanel1Cleared 510(K)
- K123418GRAM-NEGATIVE QUICKFISH BC1Cleared 510(K)
- K101558GNR TRAFFIC LIGHT PNA FISH1Cleared 510(K)
- K092236E.COLI/P. AERUGINOSA PNA FISH1Cleared 510(K)
- K092393EK/P. AERUGINOSA PNA FISH1Cleared 510(K)
- K082068E. COLI PNA FISH1Cleared 510(K)
- K081433EK/P. AERUGINOSA PNA FISH1Cleared 510(K)
- K081309E.COLI/P. AERUGINOSA PNA FISH1Cleared 510(K)
- K926002ALAMAR BACTERIAL IDENTIFICATION TEST PANEL1Cleared 510(K)
- K926017CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM1Cleared 510(K)
- K926018CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM1Cleared 510(K)
- K924814API 20E/UNISCEPT 20E1Cleared 510(K)
- K922588ROCHE ENTEROTUBE II1Cleared 510(K)
- K912924RAMBACH AGAR1Cleared 510(K)
- K894776SENSITITRE INDOLE REAGENT1Cleared 510(K)
- K890626RAPIDEC COLI1Cleared 510(K)
- K883558VITEK GRAM-NEGATIVE IDENTIFICATION CARD1Cleared 510(K)
- K863603GI MOTILITY TEST MEDIUM W/TTC1Cleared 510(K)
- K861774QUADRA-TITER (TM) I.D. (MODIFICATION)1Cleared 510(K)
- K854733API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)1Cleared 510(K)
- K853009COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT1Cleared 510(K)
- K860208QUADRA-TITER I.D.1Cleared 510(K)
- K852871IDS RAPID SS/U SYSTEM1Cleared 510(K)
- K852110IDS RAPID E PLUS SYSTEM1Cleared 510(K)
- K851978LYFO-KWIK OMI KIT1Cleared 510(K)
- K843571RIM-UREA1Cleared 510(K)
- K834090TITERTEK ENTEROBAC*1Cleared 510(K)
- K833612FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI1Cleared 510(K)
- K833613FLUOR-B MEL A DIRECT FLUORESCENT ANTI1Cleared 510(K)
- K831672SPECTRUM-101Cleared 510(K)
- K830698QUANTUM II BACTERIAL IDENT. SYSTEM1Cleared 510(K)
- K830396UREA-PDA DISK1Cleared 510(K)
- K813609RAPID E1Cleared 510(K)
- K813164SYSTEK #1 EIKEN1Cleared 510(K)
- K812286MINITECK ENTERIC BROTH & ENTEROBACTER1Cleared 510(K)
- K811765SENSITITIRE AP601Cleared 510(K)
- K811434SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS1Cleared 510(K)
- K792058ENTERIC-TEK1Cleared 510(K)
- K7917893M MICROBIAL PROFILE SYSTEM GRAM1Cleared 510(K)
- K791991STREP-SPEC1Cleared 510(K)
- K791932AMS ENTEROBACTERIACEASE CARE1Cleared 510(K)
- K782056CORD, ENTEROBACTERIACEAE BIOCHEMICAL1Cleared 510(K)
- K781816INOCULATOR, AIM-4 MICROPROCESSOR1Cleared 510(K)
- K781368MICRODILUTION GRAM-NEGATIVE ID. PANEL1Cleared 510(K)
- K781367MICRODILUTION STREP ID. PANEL1Cleared 510(K)
- K781427MS-2 BACTERIAL ID. SYSTEM1Cleared 510(K)
- K781236ENTEROTUBE II1Cleared 510(K)
- K771703ENTERIC 201Cleared 510(K)
- K760790MICRO-ID1Cleared 510(K)
- 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
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K853009
- 510(k) Type
- Traditional
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/4/1986
- Days to Decision
- 231 days