COPALIS CMV TOTAL ANTIBODY ASSAY— 510(k) K955799

Substantially Equivalent

Sienna Biotech, Inc.

FDA 510(k) clearance K955799 for COPALIS CMV TOTAL ANTIBODY ASSAY, Substantially Equivalent on 1996-07-10. Applicant: Sienna Biotech, Inc..

Clearance details

Applicant: Sienna Biotech, Inc.
Product code: Code LJO
Advisory panel: Microbiology
Date received: 1995-12-22
Decision date: 1996-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

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