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FDA 510(k)

BUHLMANN fCAL ELISA

K-Number: K181012 · 2018-06-04

ApplicantBuhlmann Laboratories AG
Decision Date2018-06-04
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BUHLMANN fCAL ELISA 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 2018-06-04 under 510(k) 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. The listed applicant is Buhlmann Laboratories AG. The 510(k) number is K181012.

When did BUHLMANN fCAL ELISA receive FDA 510(k) clearance?

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

Who is the listed applicant for BUHLMANN fCAL ELISA?

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 ELISA?

The FDA product code for BUHLMANN fCAL ELISA 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.

K191718Buhlmann fCAL turbo and CALEX CapK190784BUHLMANN fCAL turbo

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 DeviceALPCOK191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AGK191592CalprestNG, EasyCalEurospital S.P.A.

Official Source

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