Cleared Traditional

ELECSYS TESTOSTERONE II IMMUNOASSAY

K093421 · Roche Diagnostics Corp. · Chemistry
Apr 2010
Decision
171d
Days
Class 1
Risk

About This 510(k) Submission

K093421 is an FDA 510(k) clearance for the ELECSYS TESTOSTERONE II IMMUNOASSAY, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 23, 2010, 171 days after receiving the submission on November 3, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K093421 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2009
Decision Date April 23, 2010
Days to Decision 171 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