OSOM INFLUENZA A&B TEST— 510(k) K061508

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K061508 for OSOM INFLUENZA A&B TEST, Substantially Equivalent on 2006-06-12. Applicant: Genzyme Corp.. Device class: 2.

Clearance details

Applicant: Genzyme Corp.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2006-06-01
Decision date: 2006-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.