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FDA 510(k)

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

K-Number: K170901 · 2018-04-13

ApplicantBiosystems S.A.
Decision Date2018-04-13
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is a medical device manufactured by Biosystems S.A.. It received FDA 510(k) clearance on 2018-04-13 under approval number K170901. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400?

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Biosystems S.A.. The 510(k) number is K170901.

When was ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 approved by the FDA?

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 received FDA 510(k) clearance on 2018-04-13, under approval number K170901.

What company makes ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400?

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is manufactured by Biosystems S.A..

What is the FDA product code for ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400?

The FDA product code for ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is CIX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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