Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-10-16 under approval 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. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K180971.

When was QUANTA Flash Calprotectin and Fecal Extraction Device approved by the FDA?

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

What company makes QUANTA Flash Calprotectin and Fecal Extraction Device?

QUANTA Flash Calprotectin and Fecal Extraction Device is manufactured by Inova Diagnostics, Inc..

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.

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 NCT06810518 ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool RECRUITING NCT01786317 Anal Motor Function in Fecal Incontinence COMPLETED

Other Devices by Inova Diagnostics, Inc.

K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls K152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

View all 16 devices →

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. 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.

↑