CEDIA(TM) T UPTAKE— 510(k) K872447

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K872447 for CEDIA(TM) T UPTAKE, Substantially Equivalent on 1987-08-21. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1987-06-23
Decision date: 1987-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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Recent devices under product code KHQ

K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
K980088 — T-UPTAKE MICROPLATE EIA1998-02-04
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.