COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS— 510(k) K961784

Name: FDA 510(k) clearance K961784
Creator: U.S. Food and Drug Administration
Published: 1996-10-31

Substantially Equivalent

Sienna Biotech, Inc.

FDA 510(k) clearance K961784 for COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS, Substantially Equivalent on 1996-10-31. 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: 1996-05-02
Decision date: 1996-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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