Cleared Traditional

OPTICOAT T4 EIA KIT

K982298 · Biotecx Laboratories, Inc. · Chemistry
Feb 1999
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K982298 is an FDA 510(k) clearance for the OPTICOAT T4 EIA KIT, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Biotecx Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on February 3, 1999, 217 days after receiving the submission on July 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K982298 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1998
Decision Date February 03, 1999
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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