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 a medical device manufactured by Bühlmann Laboratories AG. It received FDA 510(k) clearance on 2024-02-06 under approval 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. It is manufactured by Bühlmann Laboratories AG. The 510(k) number is K232057.
When was BÜHLMANN fCAL® turbo and CALEX® Cap approved by the FDA?
BÜHLMANN fCAL® turbo and CALEX® Cap received FDA 510(k) clearance on 2024-02-06, under approval number K232057.
What company makes BÜHLMANN fCAL® turbo and CALEX® Cap?
BÜHLMANN fCAL® turbo and CALEX® Cap is manufactured by Bühlmann Laboratories AG.
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)
K160447Calprest NGEurospital S.P.A.
K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction BufferInova Diagnostics, Inc.
K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. DeviceDiaSorin, Inc.
K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc.
K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG
K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCO
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.