Cleared Traditional

STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY

K862428 · American Dade · Chemistry
Aug 1986
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K862428 is an FDA 510(k) clearance for the STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on August 19, 1986, 54 days after receiving the submission on June 26, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K862428 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1986
Decision Date August 19, 1986
Days to Decision 54 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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