VIDAS THYROXINE (T4) ASSAY (T4)— 510(k) K926393

Name: FDA 510(k) clearance K926393
Creator: U.S. Food and Drug Administration
Published: 1993-05-13

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K926393 for VIDAS THYROXINE (T4) ASSAY (T4), Substantially Equivalent on 1993-05-13. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-12-21
Decision date: 1993-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLI

view all

K160495 — VITROS® Automation Solutions2016-10-18
K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT2013-08-14
K103484 — GSP NEONATAL THYROXINE (T4)2011-04-22
K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL2009-02-26
K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-3002003-08-22

More clearances from Biomerieux Vitek, Inc.

view all

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.