Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument— 510(k) K232286

Name: FDA 510(k) clearance K232286
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K232286 for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument, Substantially Equivalent on 2023-12-20. 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: 2023-08-01
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.