Cleared Traditional

DRG AURICA ELISA TESTOSTERONE KIT

K000043 · Drg Intl., Inc. · Chemistry
Apr 2000
Decision
102d
Days
Class 1
Risk

About This 510(k) Submission

K000043 is an FDA 510(k) clearance for the DRG AURICA ELISA TESTOSTERONE KIT, 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 April 17, 2000, 102 days after receiving the submission on January 6, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K000043 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2000
Decision Date April 17, 2000
Days to Decision 102 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