Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
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- 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
- 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
- K243625Xpert MRSA/SA SSTI2Cleared 510(K)
- K243070Xpert® SA Nasal Complete2Cleared 510(K)
- K191742ARIES MRSA Assay2Cleared 510(K)
- K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System2Cleared 510(K)
- K162444Xpert MRSA NxG2Cleared 510(K)
- K142721cobas MRSA/SA Test2Cleared 510(K)
- K133605BD MAX MRSA XT, BD MAX INSTRUMENT2Cleared 510(K)
- K132822BD MAX STAPHSR ASSAY, INSTRUMENT2Cleared 510(K)
- K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWARE2Cleared 510(K)
- K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE2Cleared 510(K)
Show All 24 Submissions
- 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
- PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2Product Code
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay2Product 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
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K190771
- 510(k) Type
- Special
- Applicant
- Cepheid
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/25/2019
- Days to Decision
- 30 days
- Submission Type
- Summary