Cleared Traditional

TSH RIA KIT

K791217 · Antibodies, Inc. · Chemistry
Sep 1979
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K791217 is an FDA 510(k) clearance for the TSH RIA KIT, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979, 64 days after receiving the submission on July 2, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K791217 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1979
Decision Date September 04, 1979
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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