Cleared Traditional

REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)

K001607 · Repromedix Corp. · Chemistry

Oct 2000

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K001607 is an FDA 510(k) clearance for the REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104), a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), 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 862.1710.

Submission Details

510(k) Number	K001607 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