Solana HSV 1+2/VZV Assay— 510(k) K162451
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K162451 for Solana HSV 1+2/VZV Assay, Substantially Equivalent on 2016-11-28. Applicant: Quidel Corporation. Device class: 2.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code PGI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3309
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
Recent devices under product code PGI
view all- K233349 — Alinity m HSV 1 & 2 / VZV
- K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
More clearances from Quidel Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.