Cleared Traditional

DSL AACTIVE DHEA EIA KIT

K955114 · Diagnostic Systems Laboratories, Inc. · Chemistry
Feb 1996
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K955114 is an FDA 510(k) clearance for the DSL AACTIVE DHEA EIA KIT, 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 February 23, 1996, 106 days after receiving the submission on November 9, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1245.

Submission Details

510(k) Number K955114 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1995
Decision Date February 23, 1996
Days to Decision 106 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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