DSL SOMATOMEDIN-C (DSL #5600)— 510(k) K875229

Name: FDA 510(k) clearance K875229
Creator: U.S. Food and Drug Administration
Published: 1988-07-01

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K875229 for DSL SOMATOMEDIN-C (DSL #5600), Substantially Equivalent on 1988-07-01. 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: 1987-12-22
Decision date: 1988-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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