DSL INSULIN RIA (DSL 1600)— 510(k) K914820

Name: FDA 510(k) clearance K914820
Creator: U.S. Food and Drug Administration
Published: 1992-01-09

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K914820 for DSL INSULIN RIA (DSL 1600), Substantially Equivalent on 1992-01-09. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1991-10-25
Decision date: 1992-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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