THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST— 510(k) K000687

Name: FDA 510(k) clearance K000687
Creator: U.S. Food and Drug Administration
Published: 2000-06-12

Substantially Equivalent

Beacon Biologicals, Inc.

FDA 510(k) clearance K000687 for THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST, Substantially Equivalent on 2000-06-12. Applicant: Beacon Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Beacon Biologicals, Inc.
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 2000-02-29
Decision date: 2000-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

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