T3 UPTAKE (T3U) REAGENTS— 510(k) K792607

Name: FDA 510(k) clearance K792607
Creator: U.S. Food and Drug Administration
Published: 1980-01-16

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K792607 for T3 UPTAKE (T3U) REAGENTS, Substantially Equivalent on 1980-01-16. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1979-12-18
Decision date: 1980-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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

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K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL,1980-02-13
K792723 — BLOOD FLUID FILTERS1980-01-21
K792443 — TSH RADIOIMMUNOASSAY1979-12-27
K792442 — FERRITIN RADIOIMMUNOASSAY1979-12-18

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