ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT— 510(k) K821553

Name: FDA 510(k) clearance K821553
Creator: U.S. Food and Drug Administration
Published: 1982-06-25

Substantially Equivalent

Amf Biological and Diagnostics Co.

FDA 510(k) clearance K821553 for ZETAPHASE T3 UPTAKE DIAGNOSTIC 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 KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
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 ↗

Recent devices under product code KHQ

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K970539 — CHIRON DIAGNOSTICS ACS:180TU P1997-03-24
K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)1996-11-27
K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

More clearances from Amf Biological and Diagnostics Co.

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K852418 — QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)1985-07-15
K821931 — ZETA-CORT1982-07-22
K821554 — ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT1982-06-25
K812329 — ZETA-SERA D1981-09-01

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