COPALIS CMV TOTAL ANTIBODY ASSAY— 510(k) K955799

Name: FDA 510(k) clearance K955799
Creator: U.S. Food and Drug Administration
Published: 1996-07-10

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.. Device class: 2.

Clearance details

Applicant: Sienna Biotech, Inc.
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1995-12-22
Decision date: 1996-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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