ENZYNATIC TRIGLYCERIDES REAGENT SET— 510(k) K855164

Name: FDA 510(k) clearance K855164
Creator: U.S. Food and Drug Administration
Published: 1986-02-19

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K855164 for ENZYNATIC TRIGLYCERIDES REAGENT SET, Substantially Equivalent on 1986-02-19. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1985-12-26
Decision date: 1986-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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