TOTAL BILIRUBIN— 510(k) K022339

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K022339 for TOTAL BILIRUBIN, Substantially Equivalent on 2002-09-13. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2002-07-18
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.