FDA 510(k)

BUHLMANN fCAL turbo

K-Number: K190784 · 2019-06-25

Decision Date2019-06-25

Product CodeNXO

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

BUHLMANN fCAL turbo is a medical device manufactured by Buhlmann Laboratories AG. It received FDA 510(k) clearance on 2019-06-25 under approval number K190784. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUHLMANN fCAL turbo?

BUHLMANN fCAL turbo is a medical device that received FDA 510(k) clearance on 2019-06-25. It is manufactured by Buhlmann Laboratories AG. The 510(k) number is K190784.

When was BUHLMANN fCAL turbo approved by the FDA?

BUHLMANN fCAL turbo received FDA 510(k) clearance on 2019-06-25, under approval number K190784.

What company makes BUHLMANN fCAL turbo?

BUHLMANN fCAL turbo is manufactured by Buhlmann Laboratories AG.

What is the FDA product code for BUHLMANN fCAL turbo?

The FDA product code for BUHLMANN fCAL turbo is NXO.

Other Devices by Buhlmann Laboratories AG

K181012BUHLMANN fCAL ELISA K191718Buhlmann fCAL turbo and CALEX Cap

Related Devices (Code: NXO)

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Official Source

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