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 IDK210137
510k NumberK210137
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
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia,  PA  19103
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-02-18

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