Cleared Special

IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE

K032881 · Diagnostic Products Corp. · Chemistry
Oct 2003
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K032881 is an FDA 510(k) clearance for the IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 10, 2003, 25 days after receiving the submission on September 15, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K032881 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2003
Decision Date October 10, 2003
Days to Decision 25 days
Submission Type Special
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