Cleared Traditional

DRG SLV TESTOSTERONE ELISA TEST

K052649 · Drg Intl., Inc. · Chemistry
Jan 2006
Decision
123d
Days
Class 1
Risk

About This 510(k) Submission

K052649 is an FDA 510(k) clearance for the DRG SLV TESTOSTERONE ELISA TEST, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Drg Intl., Inc. (East Stroudsburg, US). The FDA issued a Cleared decision on January 27, 2006, 123 days after receiving the submission on September 26, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K052649 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2005
Decision Date January 27, 2006
Days to Decision 123 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