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FDA 510(k), K192063, PGDx elio tissue complete
FDA 510(k), K192063, PGDx elio tissue complete
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510(K) Number: K192063
Device Name: PGDx elio tissue complete
Manufacturer: Jennifer Dickey
Device Classification Name: Next Generation Sequencing Based Tumor Profiling Test
Regulation Number: PZM
Classification Product Code: 08/01/2019
Date Received: 04/24/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: PGDx elio tissue complete
Manufacturer: Jennifer Dickey
Device Classification Name: Next Generation Sequencing Based Tumor Profiling Test
Regulation Number: PZM
Classification Product Code: 08/01/2019
Date Received: 04/24/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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