CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)— 510(k) K962890

Name: FDA 510(k) clearance K962890
Creator: U.S. Food and Drug Administration
Published: 1996-09-27

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K962890 for CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST), Substantially Equivalent on 1996-09-27. 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: 1996-07-24
Decision date: 1996-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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