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FDA 510(k)

ALPCO Calprotectin Immunoturbidimetric Assay

K-Number: K220763 · 2023-04-13

ApplicantALPCO
Decision Date2023-04-13
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPCO Calprotectin Immunoturbidimetric Assay is the device name listed in this FDA 510(k) record. The listed applicant is ALPCO. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K220763. 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 Immunoturbidimetric Assay?

ALPCO Calprotectin Immunoturbidimetric Assay is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is ALPCO. The 510(k) number is K220763.

When did ALPCO Calprotectin Immunoturbidimetric Assay receive FDA 510(k) clearance?

ALPCO Calprotectin Immunoturbidimetric Assay received FDA 510(k) clearance on 2023-04-13, under 510(k) number K220763.

Who is the listed applicant for ALPCO Calprotectin Immunoturbidimetric Assay?

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 Immunoturbidimetric Assay?

The FDA product code for ALPCO Calprotectin Immunoturbidimetric Assay 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.

K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

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 AGK213858LIAISON 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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