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FDA 510(k)

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

K-Number: K191807 · 2019-10-25

ApplicantALPCO
Decision Date2019-10-25
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is the device name listed in this FDA 510(k) record. The listed applicant is ALPCO. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191807. 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 ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is ALPCO. The 510(k) number is K191807.

When did ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device receive FDA 510(k) clearance?

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191807.

Who is the listed applicant for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

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

What is the FDA product code for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

The FDA product code for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is NXO.

Related Clinical Trials

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.

NCT06810518ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human StoolRECRUITINGNCT07089420ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy SubjectsCOMPLETED

Other records listing ALPCO 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.

K220763ALPCO Calprotectin Immunoturbidimetric Assay

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.K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AGK191592CalprestNG, 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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