ABBOTT ARCHITECT CEA— 510(k) K990774

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K990774 for ABBOTT ARCHITECT CEA, Substantially Equivalent on 1999-05-11. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1999-03-09
Decision date: 1999-05-11
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.