Cleared Traditional

DELFIA TESTTOSTERONE KIT

K932951 · Wallac OY · Chemistry
Aug 1993
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K932951 is an FDA 510(k) clearance for the DELFIA TESTTOSTERONE KIT, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on August 3, 1993, 47 days after receiving the submission on June 17, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K932951 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1993
Decision Date August 03, 1993
Days to Decision 47 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