DSL ERYTHROPOIETIN (DSL # 1100)— 510(k) K903492

Name: FDA 510(k) clearance K903492
Creator: U.S. Food and Drug Administration
Published: 1990-10-26

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K903492 for DSL ERYTHROPOIETIN (DSL # 1100), Substantially Equivalent on 1990-10-26. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1990-08-03
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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