Cleared Traditional

PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT

K862483 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Jan 1987
Decision
198d
Days
Class 1
Risk

About This 510(k) Submission

K862483 is an FDA 510(k) clearance for the PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on January 14, 1987, 198 days after receiving the submission on June 30, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K862483 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1986
Decision Date January 14, 1987
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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