Cleared Traditional

TESTOTERONE ELISA

K973900 · Kmi Diagnostics, Inc. · Chemistry
Feb 1998
Decision
133d
Days
Class 1
Risk

About This 510(k) Submission

K973900 is an FDA 510(k) clearance for the TESTOTERONE ELISA, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Kmi Diagnostics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 24, 1998, 133 days after receiving the submission on October 14, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K973900 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1997
Decision Date February 24, 1998
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680