Cleared Traditional

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

K904666 · Amersham Corp. · Chemistry
Nov 1990
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K904666 is an FDA 510(k) clearance for the AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on November 2, 1990, 18 days after receiving the submission on October 15, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K904666 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1990
Decision Date November 02, 1990
Days to Decision 18 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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