ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT— 510(k) K821554

Name: FDA 510(k) clearance K821554
Creator: U.S. Food and Drug Administration
Published: 1982-06-25

Substantially Equivalent

Amf Biological and Diagnostics Co.

FDA 510(k) clearance K821554 for ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT, Substantially Equivalent on 1982-06-25. Applicant: Amf Biological and Diagnostics Co.. Device class: 2.

Clearance details

Applicant: Amf Biological and Diagnostics Co.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1982-05-25
Decision date: 1982-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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