INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT— 510(k) K870828

Name: FDA 510(k) clearance K870828
Creator: U.S. Food and Drug Administration
Published: 1987-03-13

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K870828 for INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT, Substantially Equivalent on 1987-03-13. Applicant: Intersect Systems, Inc.. Device class: 1.

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1987-03-03
Decision date: 1987-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longview, WA, US

Download summary PDF View on FDA.gov ↗

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