FDA 510(k)

BUHLMANN fCAL ELISA

K-Number: K181012 · 2018-06-04

Decision Date2018-06-04

Product CodeNXO

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

BUHLMANN fCAL ELISA is a medical device manufactured by Buhlmann Laboratories AG. It received FDA 510(k) clearance on 2018-06-04 under approval number K181012. 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 ELISA?

BUHLMANN fCAL ELISA is a medical device that received FDA 510(k) clearance on 2018-06-04. It is manufactured by Buhlmann Laboratories AG. The 510(k) number is K181012.

When was BUHLMANN fCAL ELISA approved by the FDA?

BUHLMANN fCAL ELISA received FDA 510(k) clearance on 2018-06-04, under approval number K181012.

What company makes BUHLMANN fCAL ELISA?

BUHLMANN fCAL ELISA is manufactured by Buhlmann Laboratories AG.

What is the FDA product code for BUHLMANN fCAL ELISA?

The FDA product code for BUHLMANN fCAL ELISA is NXO.

Other Devices by Buhlmann Laboratories AG

K191718Buhlmann fCAL turbo and CALEX Cap K190784BUHLMANN fCAL turbo

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. K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCO K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG

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.