Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems— 510(k) K161619
Substantially EquivalentCepheid
FDA 510(k) clearance K161619 for Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems, Substantially Equivalent on 2016-08-29. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code OUY
- Device class
- Class 2
- Regulation
- 21 CFR 866.3860
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code OUY
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- K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT
- K161182 — Solana Trichomonas Assay
- K151565 — Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
More clearances from Cepheid
view allData sourced from openFDA. This site is unofficial and independent of the FDA.