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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 the device name listed in this FDA 510(k) record. The listed applicant is Buhlmann Laboratories AG. It received FDA 510(k) clearance on 2019-09-24 under 510(k) 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. The listed applicant is Buhlmann Laboratories AG. The 510(k) number is K191718.

When did Buhlmann fCAL turbo and CALEX Cap receive FDA 510(k) clearance?

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

Who is the listed applicant for Buhlmann fCAL turbo and CALEX Cap?

The FDA 510(k) record lists Buhlmann Laboratories AG as the applicant. This does not by itself establish the device manufacturer.

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 records listing Buhlmann Laboratories AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190784BUHLMANN fCAL turboK181012BUHLMANN fCAL ELISA

Related Devices (Code: NXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AGK220763ALPCO Calprotectin Immunoturbidimetric AssayALPCOK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCOK191592CalprestNG, EasyCalEurospital S.P.A.K191589Calprest, EasyCalEurospital S.P.A.

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.

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