Cleared Traditional

THYROID STIMULATING HORMONE METHOD

K970393 · Dade Chemistry Systems, Inc. · Chemistry
Mar 1997
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K970393 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE METHOD, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Dade Chemistry Systems, Inc. (Glasgow, US). The FDA issued a Cleared decision on March 3, 1997, 28 days after receiving the submission on February 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K970393 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1997
Decision Date March 03, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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