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
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar2Product Code
- K190553HardyCHROM CRE2Cleared 510(K)
- K181092CHROMID CARBA agar (CARB)2Cleared 510(K)
- K171061MRSASelect II2Cleared 510(K)
- K162620Remel Spectra ESBL2Cleared 510(K)
- K160512HardyCHROM ESBL2Cleared 510(K)
- K162076chromID MRSA2Cleared 510(K)
- K151688chromID MRSA2Cleared 510(K)
- K122187VRESELECT CULTURE MEDIUM2Cleared 510(K)
- K103684VRESELECT CULTURE MEDIUM2Cleared 510(K)
- K102922HARDYCHROM MRSA2Cleared 510(K)
- K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS2Cleared 510(K)
- K092407REMEL SPECTRA MRSA2Cleared 510(K)
- K092767BBL CHROMAGAR MRSA II2Cleared 510(K)
- K092819REMEL SPECTRA VRE2Cleared 510(K)
- K091025CHROMID VRE AGAR, MODEL: REF 43 8512Cleared 510(K)
- K091024CHROMID MRSA AGAR, MODEL: REF 43 8412Cleared 510(K)
- K081212MRSASELECT - EXTENDED INCUBATION2Cleared 510(K)
- K073027SPECTRA MRSA2Cleared 510(K)
- K070361MRSASELECT2Cleared 510(K)
- K042812BBLCHROMAGAR MRSA2Cleared 510(K)
- K972359REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN2Cleared 510(K)
- K964560BHI W/VANCOMYCIN AGAR2Cleared 510(K)
- K962744HAEMOPHILUS TEST MEDIUM AGAR (HTM)2Cleared 510(K)
- K952595HAEMOPHILUS TEST MEDIUM (HTM)2Cleared 510(K)
- K951754CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST2Cleared 510(K)
- K945569GCII AGAR WITH ISOVITALX(R) ENRICHMENT2Cleared 510(K)
- K944554BRAIN HEART INFUSION AGAR2Cleared 510(K)
- K941444BHI AGAR WITH VANCOMYCIN2Cleared 510(K)
- K941443SYNERGY QUAD2Cleared 510(K)
- K932882GC II AGAR WITH ISOVITALEX2Cleared 510(K)
- K932879G C II AGAR WITH SENSIVITALEX2Cleared 510(K)
- K923892SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA2Cleared 510(K)
- K903425HAEMOPHILUS TEST MEDIUM (HTM) BROTH2Cleared 510(K)
- K894216HAEMOPHILUS TEST MEDIUM (HTM)AGAR2Cleared 510(K)
- K894848HAEMOPHILUS TEST MEDIUM (BROTH)2Cleared 510(K)
- K892928HAEMOPHILUS TEST MEDIUM (AGAR)2Cleared 510(K)
- K881568WILKENS CHALGREN BROTH2Cleared 510(K)
- K881567WILKENS CHALGREN AGAR2Cleared 510(K)
- K811513WILKINS-CHALGREN ANAEROBE AGAR2Cleared 510(K)
- K770441GAR, COLUMBIA, W/5% HORSE BLOOD2Cleared 510(K)
- JTNSusceptibility Test Discs, Antimicrobial2Product Code
- JTTSusceptibility Test Powders, Antimicrobial2Product Code
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth2Product Code
- JWYManual Antimicrobial Susceptibility Test Systems2Product Code
- LIEReagent/Device, Inoculum Calibration2Product Code
- LKACulture Media, Antimicrobial Susceptibility Test2Product Code
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2Product Code
- LOPSolution, Antimicrobial2Product Code
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems2Product Code
- LTTPanels, Test, Susceptibility, Antimicrobial2Product Code
- LTWSusceptibility Test Cards, Antimicrobial2Product Code
- LTXDiscs, Elution2Product Code
- MJASusceptibility Test Powders, Antimycobacterial2Product Code
- MJDCulture Media, Antimycobacteria, Susceptibility Test2Product Code
- MJECulture Media, Antifungal, Susceptibility Test2Product Code
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2Product Code
- NGZSusceptibility Test Plate, Antifungal2Product Code
- NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species2Product Code
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2Product Code
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony2Product Code
- POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen2Product Code
- PRHPositive Blood Culture Identification And Ast Kit2Product Code
- PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2Product Code
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay2Product Code
- QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing2Product Code
- SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples2Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- 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
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K945569
- 510(k) Type
- Traditional
- Applicant
- BECTON DICKINSON MICROBIOLOGY SYSTEMS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/2/1995
- Days to Decision
- 114 days
- Submission Type
- Summary