TRIGLYCERIDES REAGENT GPO 5 X CONC.— 510(k) K903897

Name: FDA 510(k) clearance K903897
Creator: U.S. Food and Drug Administration
Published: 1990-10-01

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K903897 for TRIGLYCERIDES REAGENT GPO 5 X CONC., Substantially Equivalent on 1990-10-01. Applicant: Trace Scientific , Ltd.. Device class: 1.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1990-08-23
Decision date: 1990-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Australia 3168, AU

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