Sofia 2 Lyme FIA, Sofia Lyme Control Set— 510(k) K173496

Name: FDA 510(k) clearance K173496
Creator: U.S. Food and Drug Administration
Published: 2018-08-30

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K173496 for Sofia 2 Lyme FIA, Sofia Lyme Control Set, Substantially Equivalent on 2018-08-30. 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: 2017-11-13
Decision date: 2018-08-30
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego,, CA, US

Download summary PDF View on FDA.gov ↗

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