Cleared Traditional

ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

K041866 · Axis-Shield Diagnostics, Ltd. · Chemistry
Sep 2004
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K041866 is an FDA 510(k) clearance for the ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA), a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on September 29, 2004, 82 days after receiving the submission on July 9, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K041866 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2004
Decision Date September 29, 2004
Days to Decision 82 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