A1 SYSTEME 8201/2— 510(k) K841803

Substantially Equivalent

Med USA

FDA 510(k) clearance K841803 for A1 SYSTEME 8201/2, Substantially Equivalent on 1985-02-25. Applicant: Med USA. Device class: 2.

Clearance details

Applicant: Med USA
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1984-05-01
Decision date: 1985-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, 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.