Cleared Traditional

ST AIA-PACK TESTOSTERONE ASSAY

K023091 · Tosoh Medics, Inc. · Chemistry
Dec 2002
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K023091 is an FDA 510(k) clearance for the ST AIA-PACK TESTOSTERONE ASSAY, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 17, 2002, 91 days after receiving the submission on September 17, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K023091 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2002
Decision Date December 17, 2002
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680