AXSYM CA 125— 510(k) K964020

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K964020 for AXSYM CA 125, Substantially Equivalent on 1997-11-04. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1996-10-07
Decision date: 1997-11-04
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.