Cleared Traditional

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

K002294 · Biocheck, Inc. · Chemistry
Oct 2000
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K002294 is an FDA 510(k) clearance for the BIOCHECK TESTOSTERONE EIA, MODEL BC-1115, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on October 2, 2000, 67 days after receiving the submission on July 27, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K002294 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2000
Decision Date October 02, 2000
Days to Decision 67 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