Cleared Traditional

AIA-PACK FT3 ASSAY

K991252 · Tosoh Medics, Inc. · Chemistry
May 1999
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K991252 is an FDA 510(k) clearance for the AIA-PACK FT3 ASSAY, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on May 11, 1999, 28 days after receiving the submission on April 13, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K991252 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1999
Decision Date May 11, 1999
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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