SYNTHETIC VDRL ANTIGEN— 510(k) K993633

Name: FDA 510(k) clearance K993633
Creator: U.S. Food and Drug Administration
Published: 2000-02-23

Substantially Equivalent

Centers for Disease Control and Prevention

FDA 510(k) clearance K993633 for SYNTHETIC VDRL ANTIGEN, Substantially Equivalent on 2000-02-23. Applicant: Centers for Disease Control and Prevention. Device class: 2.

Clearance details

Applicant: Centers for Disease Control and Prevention
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1999-10-27
Decision date: 2000-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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