DSL ACTIVE NON-EXTRACTION IGF-I ELISA— 510(k) K971353

Name: FDA 510(k) clearance K971353
Creator: U.S. Food and Drug Administration
Published: 1997-05-12

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K971353 for DSL ACTIVE NON-EXTRACTION IGF-I ELISA, Substantially Equivalent on 1997-05-12. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1997-04-11
Decision date: 1997-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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