Cleared Traditional

REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)

K001603 · Repromedix Corp. · Chemistry
Oct 2000
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K001603 is an FDA 510(k) clearance for the REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105), a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Repromedix Corp. (Woburn, US). The FDA issued a Cleared decision on October 5, 2000, 134 days after receiving the submission on May 24, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K001603 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2000
Decision Date October 05, 2000
Days to Decision 134 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