TOTAL BILIRUBIN REAGENT— 510(k) K003892

Name: FDA 510(k) clearance K003892
Creator: U.S. Food and Drug Administration
Published: 2001-02-20

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K003892 for TOTAL BILIRUBIN REAGENT, Substantially Equivalent on 2001-02-20. Applicant: Intersect Systems, Inc.. Device class: 2.

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2000-12-18
Decision date: 2001-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longview, WA, US

Download summary PDF View on FDA.gov ↗

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