Cleared Traditional

IMMULITE HS-TSH

K905769 · Cirrus Diagnostics, Inc. · Chemistry
Jan 1991
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K905769 is an FDA 510(k) clearance for the IMMULITE HS-TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on January 31, 1991, 35 days after receiving the submission on December 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K905769 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1990
Decision Date January 31, 1991
Days to Decision 35 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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