Cleared Traditional

ACCUSCREEN TSH

K843281 · Neometrics, Inc. · Chemistry
Sep 1984
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K843281 is an FDA 510(k) clearance for the ACCUSCREEN TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Neometrics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984, 37 days after receiving the submission on August 20, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K843281 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1984
Decision Date September 26, 1984
Days to Decision 37 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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