OSOM INFLUENZA A&B TEST , MODEL PN190— 510(k) K092633

Name: FDA 510(k) clearance K092633
Creator: U.S. Food and Drug Administration
Published: 2009-09-25

Substantially Equivalent

Genzyme Corporation

FDA 510(k) clearance K092633 for OSOM INFLUENZA A&B TEST , MODEL PN190, Substantially Equivalent on 2009-09-25. Applicant: Genzyme Corporation. Device class: 2.

Clearance details

Applicant: Genzyme Corporation
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2009-08-27
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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