Cleared Traditional

DSL DHEA-S-7

K962895 · Diagnostic Systems Laboratories, Inc. · Chemistry
Sep 1996
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K962895 is an FDA 510(k) clearance for the DSL DHEA-S-7, a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I — General Controls, product code JKC), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on September 10, 1996, 47 days after receiving the submission on July 25, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1245.

Submission Details

510(k) Number K962895 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1996
Decision Date September 10, 1996
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1245

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