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
- 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
- K852613MIC-CONCEPT SYSTEM2Cleared 510(K)
- K853596PRECEPT CEFOPERAZONE2Cleared 510(K)
- K853273PRECEPT CEFTRIAXONE2Cleared 510(K)
- K853772PRECEPT METHICILLIN2Cleared 510(K)
- K853685PRECEPT TM CARBENICILLIN2Cleared 510(K)
- K853686PRECEPT TM AMIKACIN2Cleared 510(K)
- K853684PRECEPT KANAMYCIN2Cleared 510(K)
- K853688PRECEPT TM TOBRAMYCIN2Cleared 510(K)
- K853687PRECEPT NETILMICIN 32-132Cleared 510(K)
- K853689PRECEPT TM MOXALACTAM2Cleared 510(K)
- N50510VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE2PMA Approval
- N50510VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN2PMA Approval
- N50510VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN2PMA Approval
- N50510VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN2PMA Approval
- N50510VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN2PMA Approval
- N50510VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR ERYTHROMYCIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME2PMA Approval
- N50510VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM2PMA Approval
- N50510VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM2PMA Approval
- N50510VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR OXACILLIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR CEFOXITIN2PMA Approval
- N50510VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE TETRACYCLINE2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE NORFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN2PMA Approval
- N50510VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN2PMA Approval
- N50510VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN2PMA Approval
- N50510VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN2PMA Approval
- N50510VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM2PMA Approval
- N50510VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN2PMA Approval
- N50510VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR CIPROFLOXACIN2PMA Approval
- N50510VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN2PMA Approval
- N50510VITEK GRAM POSITIVE SUSCEPTIBILITY FOR OXACILLIN2PMA Approval
- N50510VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-CEFTRIAXONE2PMA Approval
- N50510VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-AMPICILLIN/SULBACTAM2PMA Approval
- N50510VITEK 2 SYSTEM2PMA Approval
- N50510VITEK 2 SYSTEM2PMA Approval
- N50510VITEK 2 SYSTEM2PMA Approval
- N50510VITEK 2 SYSTEM2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK PIPERACILLIN/TAZOBACTAM2PMA Approval
- N50510VITEK LOMEFLOXACIN2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK IMIPENUM CARD2PMA Approval
- N50510VITEK(R) AMPICILLIN/SULBACTAM2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- N50510VITEK MINOCYCLINE CARD2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS CEFOTETAN CARD2PMA Approval
- N50510AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS2PMA Approval
- N50510AMS CEFOTETAN CARD2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- K853263PRECEPT AVGMENTIN2Cleared 510(K)
- K853053PRECEPT ERYTHROMYCIN2Cleared 510(K)
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- K850347API UNISCEPT KB2Cleared 510(K)
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- K844159API UNISCEPT MIC 100UL2Cleared 510(K)
- K844231SCEPTOR BETA-LACTAM PLUS MIC PANEL2Cleared 510(K)
- K843733API UNISCEPT KB2Cleared 510(K)
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510AMMENDMENT TO E. COLI ASC2PMA Approval
- N50510E COLI STORAGE CONDITION2PMA Approval
- N50510E COLI EXTENSION2PMA Approval
- N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD2PMA Approval
- 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
VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL
- Page Type
- PMA Approval
- Applicant
- BIOMERIEUX VITEK, INC.
- Trade Name
- VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
- Generic Name
- Susceptibility test cards, antimicrobial
- Decision Date
- 3/2/1978
- Days to Decision
- 437 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval