Cleared Traditional

NEOSCREEN ELISA TSH

K942658 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Feb 1995
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K942658 is an FDA 510(k) clearance for the NEOSCREEN ELISA TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on February 24, 1995, 263 days after receiving the submission on June 6, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K942658 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1994
Decision Date February 24, 1995
Days to Decision 263 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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