HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT— 510(k) K933722

Name: FDA 510(k) clearance K933722
Creator: U.S. Food and Drug Administration
Published: 1996-06-13

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K933722 for HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT, Substantially Equivalent on 1996-06-13. Applicant: Horizon Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1993-08-02
Decision date: 1996-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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