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FDA 510(k)

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

K-Number: K170993 · 2017-12-22

ApplicantInova Diagnostics, Inc.
Decision Date2017-12-22
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-12-22 under approval number K170993. 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 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer?

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is a medical device that received FDA 510(k) clearance on 2017-12-22. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K170993.

When was QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer approved by the FDA?

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer received FDA 510(k) clearance on 2017-12-22, under approval number K170993.

What company makes QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer?

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer?

The FDA product code for QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is NXO.

Other Devices by Inova Diagnostics, Inc.

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Related Devices (Code: NXO)

K160447Calprest NGEurospital S.P.A. 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 K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG

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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