Cleared Traditional

TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005

K991311 · Biocheck, Inc. · Chemistry
Jun 1999
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K991311 is an FDA 510(k) clearance for the TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on June 2, 1999, 47 days after receiving the submission on April 16, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K991311 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1999
Decision Date June 02, 1999
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDP — Radioimmunoassay, Total Triiodothyronine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1710

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