AMIPLIVUE HSV 1&2 ASSAY— 510(k) K140029

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K140029 for AMIPLIVUE HSV 1&2 ASSAY, Substantially Equivalent on 2014-03-26. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2014-01-06
Decision date: 2014-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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