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FDA 510(k)

Buhlmann fCAL turbo and CALEX Cap

K-Number: K191718 · 2019-09-24

ApplicantBuhlmann Laboratories AG
Decision Date2019-09-24
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Buhlmann fCAL turbo and CALEX Cap is a medical device manufactured by Buhlmann Laboratories AG. It received FDA 510(k) clearance on 2019-09-24 under approval number K191718. 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 and CALEX Cap?

Buhlmann fCAL turbo and CALEX Cap is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Buhlmann Laboratories AG. The 510(k) number is K191718.

When was Buhlmann fCAL turbo and CALEX Cap approved by the FDA?

Buhlmann fCAL turbo and CALEX Cap received FDA 510(k) clearance on 2019-09-24, under approval number K191718.

What company makes Buhlmann fCAL turbo and CALEX Cap?

Buhlmann fCAL turbo and CALEX Cap is manufactured by Buhlmann Laboratories AG.

What is the FDA product code for Buhlmann fCAL turbo and CALEX Cap?

The FDA product code for Buhlmann fCAL turbo and CALEX Cap is NXO.

Other Devices by Buhlmann Laboratories AG

K181012BUHLMANN fCAL ELISA K190784BUHLMANN fCAL turbo

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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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