COPALIS TORC TOTAL ANTIBODY ASSAY— 510(k) K970931

Substantially Equivalent

Sienna Biotech, Inc.

FDA 510(k) clearance K970931 for COPALIS TORC TOTAL ANTIBODY ASSAY, Substantially Equivalent on 1997-04-24. Applicant: Sienna Biotech, Inc..

Clearance details

Applicant: Sienna Biotech, Inc.
Product code: Code LQN
Advisory panel: Microbiology
Date received: 1997-03-07
Decision date: 1997-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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