LIQUID STABLE CHOLESTEROL REAGENT KIT— 510(k) K902678

Name: FDA 510(k) clearance K902678
Creator: U.S. Food and Drug Administration
Published: 1990-09-25

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K902678 for LIQUID STABLE CHOLESTEROL REAGENT KIT, Substantially Equivalent on 1990-09-25. Applicant: Trace Scientific , Ltd.. Device class: 1.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1990-06-19
Decision date: 1990-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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