Cleared Traditional

FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900

K001086 · Diagnostic Systems Laboratories, Inc. · Immunology
May 2000
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K001086 is an FDA 510(k) clearance for the FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 18, 2000, 44 days after receiving the submission on April 4, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K001086 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2000
Decision Date May 18, 2000
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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