TRIGLYCERIDES REAGENT SET— 510(k) K914609

Name: FDA 510(k) clearance K914609
Creator: U.S. Food and Drug Administration
Published: 1991-11-07

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K914609 for TRIGLYCERIDES REAGENT SET, Substantially Equivalent on 1991-11-07. 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: 1991-10-17
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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