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QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Ca — Inova Diagnostics, Inc. (510(k) K1709

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Ca — Inova Diagnostics, Inc. (510(k) K1709 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Ca; Applican

Device nameQUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Ca
ApplicantInova Diagnostics, Inc.
Clearance track510(k)
Submission numberK170993
DecisionSubstantially Equivalent
Decision date2017-12-22
Date received2017-04-03
Product codeNXO
Device class2
Medical specialtyImmunology
Applicant locationCA, US
SourceopenFDA device

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