ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100— 510(k) K002128

Name: FDA 510(k) clearance K002128
Creator: U.S. Food and Drug Administration
Published: 2000-12-05

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K002128 for ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100, Substantially Equivalent on 2000-12-05. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code NDR
Device class: Class 1
Regulation: 21 CFR 862.1260
Advisory panel: Clinical Chemistry
Date received: 2000-07-14
Decision date: 2000-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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