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FDA 510(k)

BÜHLMANN fCAL® turbo and CALEX® Cap

K-Number: K232057 · 2024-02-06

ApplicantBühlmann Laboratories AG
Decision Date2024-02-06
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BÜHLMANN fCAL® turbo and CALEX® Cap is the device name listed in this FDA 510(k) record. The listed applicant is Bühlmann Laboratories AG. It received FDA 510(k) clearance on 2024-02-06 under 510(k) number K232057. 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 BÜHLMANN fCAL® turbo and CALEX® Cap?

BÜHLMANN fCAL® turbo and CALEX® Cap is a medical device that received FDA 510(k) clearance on 2024-02-06. The listed applicant is Bühlmann Laboratories AG. The 510(k) number is K232057.

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

BÜHLMANN fCAL® turbo and CALEX® Cap received FDA 510(k) clearance on 2024-02-06, under 510(k) number K232057.

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

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

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

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

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.

K220763ALPCO Calprotectin Immunoturbidimetric AssayALPCOK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCOK191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AGK191592CalprestNG, EasyCalEurospital S.P.A.K191589Calprest, EasyCalEurospital S.P.A.

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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