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FDA 510(k)

QUANTA Flash Calprotectin and Fecal Extraction Device

K-Number: K180971 · 2018-10-16

ApplicantInova Diagnostics, Inc.
Decision Date2018-10-16
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA Flash Calprotectin and Fecal Extraction Device is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K180971. 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 and Fecal Extraction Device?

QUANTA Flash Calprotectin and Fecal Extraction Device is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K180971.

When did QUANTA Flash Calprotectin and Fecal Extraction Device receive FDA 510(k) clearance?

QUANTA Flash Calprotectin and Fecal Extraction Device received FDA 510(k) clearance on 2018-10-16, under 510(k) number K180971.

Who is the listed applicant for QUANTA Flash Calprotectin and Fecal Extraction Device?

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

What is the FDA product code for QUANTA Flash Calprotectin and Fecal Extraction Device?

The FDA product code for QUANTA Flash Calprotectin and Fecal Extraction Device is NXO.

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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.K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCOK191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AGK191592CalprestNG, 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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