COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY— 510(k) K992552

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K992552 for COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY, Substantially Equivalent on 1999-12-16. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LIP
Advisory panel: Microbiology
Date received: 1999-07-30
Decision date: 1999-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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