ACTIVE ANDROSTENEDIONE EIA— 510(k) K963002

Name: FDA 510(k) clearance K963002
Creator: U.S. Food and Drug Administration
Published: 1996-08-16

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K963002 for ACTIVE ANDROSTENEDIONE EIA, Substantially Equivalent on 1996-08-16. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code CIZ
Device class: Class 1
Regulation: 21 CFR 862.1075
Advisory panel: Clinical Chemistry
Date received: 1996-08-02
Decision date: 1996-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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