Cleared Traditional

IMMUBEAD THYROID UPTAKE

K872172 · Immunotech Corp. · Chemistry
Aug 1987
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K872172 is an FDA 510(k) clearance for the IMMUBEAD THYROID UPTAKE, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on August 17, 1987, 70 days after receiving the submission on June 8, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K872172 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1987
Decision Date August 17, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

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