T3 UPTAKE TEST SYSTEM— 510(k) K802468

Name: FDA 510(k) clearance K802468
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K802468 for T3 UPTAKE TEST SYSTEM, Substantially Equivalent on 1980-10-31. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1980-10-09
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

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