Sofia Lyme FIA, Sofia Lyme Control Set— 510(k) K163713

Name: FDA 510(k) clearance K163713
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K163713 for Sofia Lyme FIA, Sofia Lyme Control Set, Substantially Equivalent on 2017-10-20. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2016-12-30
Decision date: 2017-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego,, CA, US

Download summary PDF View on FDA.gov ↗

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