Cleared Traditional

K883123 - AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
(FDA 510(k) Clearance)

K883123 · Amersham Corp. · Chemistry

Dec 1988

Decision

149d

Days

Class 2

Risk

K883123 is an FDA 510(k) clearance for the AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on December 22, 1988, 149 days after receiving the submission on July 26, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K883123 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 1988
Decision Date	December 22, 1988
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—