ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)— 510(k) K860717

Name: FDA 510(k) clearance K860717
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K860717 for ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL), Substantially Equivalent on 1986-04-11. 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: 1986-02-26
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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