Cleared Traditional

MICROZYME TSH ENZYME IMMUNOASSAY KIT

K910411 · Immunotech Corp. · Chemistry
Apr 1991
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K910411 is an FDA 510(k) clearance for the MICROZYME TSH ENZYME IMMUNOASSAY KIT, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on April 3, 1991, 64 days after receiving the submission on January 29, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K910411 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1991
Decision Date April 03, 1991
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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