ABBOTT IMX 2 ANALYZER— 510(k) K944731

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K944731 for ABBOTT IMX 2 ANALYZER, Substantially Equivalent on 1994-12-19. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JJI
Device class: Class 1
Regulation: 21 CFR 862.2500
Advisory panel: Clinical Chemistry
Date received: 1994-09-12
Decision date: 1994-12-19
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.