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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 a medical device manufactured by ALPCO. It received FDA 510(k) clearance on 2023-04-13 under approval 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. It is manufactured by ALPCO. The 510(k) number is K220763.

When was ALPCO Calprotectin Immunoturbidimetric Assay approved by the FDA?

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

What company makes ALPCO Calprotectin Immunoturbidimetric Assay?

ALPCO Calprotectin Immunoturbidimetric Assay is manufactured by ALPCO.

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

NCT07565064 ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study ENROLLING_BY_INVITATION NCT06810518 ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool RECRUITING NCT07089420 ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects COMPLETED

Other Devices by ALPCO

K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

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.

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