ABBOTT ARCHITECT FOLATE— 510(k) K023397

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K023397 for ABBOTT ARCHITECT FOLATE, Substantially Equivalent on 2002-12-16. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 2002-10-09
Decision date: 2002-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, 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.