GAMMA COAT(125 I) RUBELLA ANTIBODY— 510(k) K801667

Name: FDA 510(k) clearance K801667
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Clinical Assays, Inc.

FDA 510(k) clearance K801667 for GAMMA COAT(125 I) RUBELLA ANTIBODY, Substantially Equivalent on 1980-10-23. Applicant: Clinical Assays, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Assays, Inc.
Product code: Code GOL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1980-07-21
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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