Alinity m HSV 1 & 2 / VZV— 510(k) K233349
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K233349 for Alinity m HSV 1 & 2 / VZV, Substantially Equivalent on 2024-05-03. Applicant: Abbott Molecular, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Molecular, Inc.
- 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
- Des Plaines, IL, US
Recent devices under product code PGI
view all- 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
- K162451 — Solana HSV 1+2/VZV Assay
More clearances from Abbott Molecular, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.