Cleared Traditional

IMMUBEAD T3 ENZYME IMMUNOASSAY KIT

K872191 · Immunotech Corp. · Chemistry
Aug 1987
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K872191 is an FDA 510(k) clearance for the IMMUBEAD T3 ENZYME IMMUNOASSAY KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on August 13, 1987, 66 days after receiving the submission on June 8, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K872191 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1987
Decision Date August 13, 1987
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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