510(k) K170901— ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

Substantially Equivalent

Biosystems S.A.

Clearance details

Applicant: Biosystems S.A.
Product code: Code CIX
Advisory panel: Clinical Chemistry
Date received: 2017-03-27
Decision date: 2018-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

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