VIDAS T UPTAKE— 510(k) K935816

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K935816 for VIDAS T UPTAKE, Substantially Equivalent on 1994-03-22. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1993-12-02
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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

More clearances from Biomerieux Vitek, Inc.

K973819 — VIDAS D-DIMER (DD) ASSAY1998-03-10
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05
K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY1997-04-08
K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY1996-10-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.