Cleared Traditional

AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT

K893469 · Amersham Corp. · Toxicology
Aug 1989
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K893469 is an FDA 510(k) clearance for the AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on August 15, 1989, 103 days after receiving the submission on May 4, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number K893469 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1989
Decision Date August 15, 1989
Days to Decision 103 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code CEE — Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1685

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