Cleared Traditional

AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT

K885195 · Amersham Corp. · Chemistry
Feb 1989
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K885195 is an FDA 510(k) clearance for the AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on February 8, 1989, 54 days after receiving the submission on December 16, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K885195 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1988
Decision Date February 08, 1989
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDP — Radioimmunoassay, Total Triiodothyronine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1710

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