Cleared Traditional

SIA THYROID STIMULATING HORMONE ELISA KIT

K930050 · Sigma Chemical Co. · Chemistry
Aug 1993
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K930050 is an FDA 510(k) clearance for the SIA THYROID STIMULATING HORMONE ELISA KIT, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on August 19, 1993, 226 days after receiving the submission on January 5, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K930050 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1993
Decision Date August 19, 1993
Days to Decision 226 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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