Cleared Traditional

K865071 - THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
(FDA 510(k) Clearance)

K865071 · Immuchem Corp. · Chemistry

Mar 1987

Decision

74d

Days

Class 2

Risk

K865071 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on March 13, 1987, 74 days after receiving the submission on December 29, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number	K865071 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 1986
Decision Date	March 13, 1987
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—