DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)— 510(k) K904100

Name: FDA 510(k) clearance K904100
Creator: U.S. Food and Drug Administration
Published: 1990-10-15

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K904100 for DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300), Substantially Equivalent on 1990-10-15. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1990-09-06
Decision date: 1990-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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