ELECSYS T-UPTAKE ASSAY— 510(k) K961488

Name: FDA 510(k) clearance K961488
Creator: U.S. Food and Drug Administration
Published: 1996-06-12

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K961488 for ELECSYS T-UPTAKE ASSAY, Substantially Equivalent on 1996-06-12. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1996-04-18
Decision date: 1996-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, 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
K954807 — CEDIA T UPTAKE ASSAY1995-12-21

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