T4 RADIOIMMUNOASSAY KIT— 510(k) K802469

Name: FDA 510(k) clearance K802469
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K802469 for T4 RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1980-11-12. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1980-10-09
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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