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
- 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
- K222591BD BACTEC™ Plus Aerobic/F Culture Vials1Cleared 510(K)
- K222559BD BACTEC™ Myco/F Lytic Culture Vials1Cleared 510(K)
- K190405BACT/ALERT MP Reagent System1Cleared 510(K)
- K183166BacT/ALERT FA Plus; BacT/ALERT PF Plus1Cleared 510(K)
- K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial1Cleared 510(K)
- K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO1Cleared 510(K)
- K161810BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial1Cleared 510(K)
- K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial1Cleared 510(K)
- K151866BD BACTEC Peds Plus/F Culture Vials (plastic)1Cleared 510(K)
- K141810BD BACTEC PLUS ANAEROBIC/F (PLASTIC)1Cleared 510(K)
- K123903BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)1Cleared 510(K)
- K121455BACT/ALERT FN PLUS CULTURE BOTTLE1Cleared 510(K)
- K121446BACT/ALERT PF PLUS CULTURE BOTTLE1Cleared 510(K)
- K121461BACT/ALERT FA PLUS CULTURE BOTTLE1Cleared 510(K)
- K120994BD BACTEC Plus PRIME Aerobic/F Culture Vials1Cleared 510(K)
- K113558BD BACTEC Plus Aerobic/F Culture Vials (plastic)1Cleared 510(K)
- K083572BD BACTEC Plus Aerobic/F Culture Vials1Cleared 510(K)
- K032306VERSATREK1Cleared 510(K)
- K031737BACT/ALERT MP CULTURE BOTTLES (PLASTIC)1Cleared 510(K)
- K021123BACT/ALERT SN CULTURE BOTTLE1Cleared 510(K)
- K020931BACT/ALERT SA CULTURE BOTTLE1Cleared 510(K)
- K020923BACT/ALERT PF CULTURE BOTTLE1Cleared 510(K)
- K020815BACT/ALERT FN CULTURE BOTTLE1Cleared 510(K)
- K020813BACT/ALERT FA CULTURE BOTTLE1Cleared 510(K)
- K000378BACT/ALERT MB CULTURE BOTTLE1Cleared 510(K)
- K994343BACT/ALERT SV1Cleared 510(K)
- K993423BACT/ALERT SA1Cleared 510(K)
- K993576BACT/ALERT MP PROCESS BOTTLE1Cleared 510(K)
- K993421BACT/ALERT SN1Cleared 510(K)
- K992432BACT/ALERT FN1Cleared 510(K)
- K992401BACT/ALERT PF1Cleared 510(K)
- K992400BACTALERT FA1Cleared 510(K)
- K983772MB/BACT BLOOD CULTURE BOTTLE1Cleared 510(K)
- K982263MB/BACT BLOOD CULTURE BOTTLE1Cleared 510(K)
- K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEM1Cleared 510(K)
- K974883BACTEC MGIT 960 SYSTEM1Cleared 510(K)
- K970333BACTEC MYCO/F LYTIC CULTURE VIALS1Cleared 510(K)
- K970512BACTEC MYCO/F LYTIC CULTURE VIALS1Cleared 510(K)
- K973325BACT/ALERT FAN CULTURE BOTTLES1Cleared 510(K)
- K973305BACT/ALERT CULTURE BOTTLES1Cleared 510(K)
- K972758BACTEC MYCO/F-SPUTA CULTURE VIALS1Cleared 510(K)
- K972756MODIFICATION OF EST CULTURE SYSTEM II - MYCO1Cleared 510(K)
- K954932BBL MGIT PRODUCTS1Cleared 510(K)
- K962210BACTEC 9050 SYSTEM1Cleared 510(K)
- K954468MB/BACT MYCROBACTERIA DETECTION SYSTEM1Cleared 510(K)
- K946268BACTEC(R) 9000TB SYSTEM1Cleared 510(K)
- K954930BACTEC CULTURE VIALS, LYTIC, ANAEROBIC1Cleared 510(K)
- K954925BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS1Cleared 510(K)
- K954927BACTEC PEDS PLUS/F CULTURE VIALS1Cleared 510(K)
- K954921BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS1Cleared 510(K)
- K954924BACTEC PEDS PLUS CLUTURE VIALS1Cleared 510(K)
- K953129ESP CULTURE SYSTEM - MYCO1Cleared 510(K)
- K944594BACT/ALERT FAN CULTURE BOTTLE1Cleared 510(K)
- K935711BACT/ALERT FAN AEROBIC CULTURE BOTTLE1Cleared 510(K)
- K934593BACT/ALERT 1201Cleared 510(K)
- K926304BACTEC PEDS PLUS/F1Cleared 510(K)
- K925693EZ VIEW1Cleared 510(K)
- K921637ESP BLOOD CULTURE SYSTEM1Cleared 510(K)
- K922475BACTEC 9120 SYSTEM1Cleared 510(K)
- K920249BACT/ALERT PEDI-BACT1Cleared 510(K)
- K921133BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA1Cleared 510(K)
- K915796BACTEC 9240 SYSTEM1Cleared 510(K)
- K920933BACTEC FOS CULTURE SUPPLEMENT1Cleared 510(K)
- K903505BACT/ALERT (TM)1Cleared 510(K)
- K833888PENASE1Cleared 510(K)
- K812315BACTEC RESIN CULTURE MED. 16A1Cleared 510(K)
- 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
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K981736
- 510(k) Type
- Traditional
- Applicant
- ORGANON TEKNIKA CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/24/1998
- Days to Decision
- 67 days
- Submission Type
- Summary