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

Name: FDA 510(k) clearance K170901
Creator: U.S. Food and Drug Administration
Published: 2018-04-13

Substantially Equivalent

Biosystems S.A.

FDA 510(k) clearance K170901 for ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400, Substantially Equivalent on 2018-04-13. Applicant: Biosystems S.A.. Device class: 2.

Clearance details

Applicant: Biosystems S.A.
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 2017-03-27
Decision date: 2018-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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