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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 a medical device manufactured by ALPCO. It received FDA 510(k) clearance on 2019-10-25 under approval 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. It is manufactured by ALPCO. The 510(k) number is K191807.

When was ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device approved by the FDA?

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

What company makes ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is manufactured by ALPCO.

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

NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED NCT05536115 Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket COMPLETED NCT06977633 Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes NOT_YET_RECRUITING NCT07565064 ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study ENROLLING_BY_INVITATION

Other Devices by ALPCO

K220763ALPCO Calprotectin Immunoturbidimetric Assay

Related Devices (Code: NXO)

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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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