PGDx Elio Tissue Complete

Next Generation Sequencing Based Tumor Profiling Test

Personal Genome Diagnostics

The following data is part of a premarket notification filed by Personal Genome Diagnostics with the FDA for Pgdx Elio Tissue Complete.

Pre-market Notification Details

Device IDK192063
510k NumberK192063
Device Name:PGDx Elio Tissue Complete
ClassificationNext Generation Sequencing Based Tumor Profiling Test
Applicant Personal Genome Diagnostics 2809 Boston Street, Suite 503 Baltimore,  MD  21224
ContactJennifer Dickey
CorrespondentJennifer Dickey
Personal Genome Diagnostics 2809 Boston Street, Suite 503 Baltimore,  MD  21224
Product CodePZM  
CFR Regulation Number866.6080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-01
Decision Date2020-04-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00192721001418 K192063 000
00192721000763 K192063 000
00192721000770 K192063 000
00192721001418 K192063 000
00192721000756 K192063 000
00192721000763 K192063 000
00192721000770 K192063 000
00192721001418 K192063 000
00192721000756 K192063 000
00192721000763 K192063 000
00192721000770 K192063 000
00192721000756 K192063 000

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