AMPLIVUE GBS ASSAY— 510(k) K133503

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K133503 for AMPLIVUE GBS ASSAY, Substantially Equivalent on 2013-12-20. Applicant: Quidel Corporation. Device class: 1.

Clearance details

Applicant: Quidel Corporation
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2013-11-14
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

Download summary PDF View on FDA.gov ↗

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