COPALIS TORC TOTAL ANTIBODY ASSAY— 510(k) K970931

Name: FDA 510(k) clearance K970931
Creator: U.S. Food and Drug Administration
Published: 1997-04-24

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.. Device class: 2.

Clearance details

Applicant: Sienna Biotech, Inc.
Product code: Code LQN
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1997-03-07
Decision date: 1997-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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