Cleared Traditional

IMMULITE(TM) TOTAL T4

K910261 · Cirrus Diagnostics, Inc. · Chemistry
Apr 1991
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K910261 is an FDA 510(k) clearance for the IMMULITE(TM) TOTAL T4, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on April 16, 1991, 84 days after receiving the submission on January 22, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K910261 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1991
Decision Date April 16, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

Similar Devices — KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 85
VITROS? Automation Solutions
K160495 · Ortho-Clinical Diagnostics, Inc. · Oct 2016
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
K131515 · Alfa Wassermann · Aug 2013
GSP NEONATAL THYROXINE (T4)
K103484 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Apr 2011
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · Siemens Healthcare Diagnostics, Inc. · Feb 2009
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
K030860 · Monobind · Aug 2003
ACCESS TOTAL T4 ASSAY
K023369 · Beckman Coulter, Inc. · Dec 2002