AKS II— 510(k) K895095

Substantially Equivalent

Amoco Technology Co.

FDA 510(k) clearance K895095 for AKS II, Substantially Equivalent on 1990-02-09. Applicant: Amoco Technology Co.. Device class: 2.

Clearance details

Applicant: Amoco Technology Co.
Product code: Code LNJ
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 1989-08-14
Decision date: 1990-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naperville, IL, US

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