EsoCheck Cell Collection Device

Esophagoscope (flexible Or Rigid)

Lucid Diagnostics, Inc.

The following data is part of a premarket notification filed by Lucid Diagnostics, Inc. with the FDA for Esocheck Cell Collection Device.

Pre-market Notification Details

Device IDK222366
510k NumberK222366
Device Name:EsoCheck Cell Collection Device
ClassificationEsophagoscope (flexible Or Rigid)
Applicant Lucid Diagnostics, Inc. One Grand Central Place, Suite 4600 New York,  NY  10165
ContactLishan Aklog
CorrespondentKelliann Payne
Hogan Lovells US LPP 1735 Market Street Floor 23 Philladelphia,  PA  19103
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-04
Decision Date2022-10-26

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