GENZYME OSOM TRICHOMONAS RAPID TEST— 510(k) K033864

Name: FDA 510(k) clearance K033864
Creator: U.S. Food and Drug Administration
Published: 2004-04-02

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K033864 for GENZYME OSOM TRICHOMONAS RAPID TEST, Substantially Equivalent on 2004-04-02. Applicant: Genzyme Corp.. Device class: 1.

Clearance details

Applicant: Genzyme Corp.
Product code: Code JWZ
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2003-12-12
Decision date: 2004-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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