Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EsoCheck CCD Cell Collection Device

K-Number: K183262 · 2019-06-21

ApplicantLucid Diagnostics, Inc.
Decision Date2019-06-21
Product CodeEOX
Advisory CommitteeEN
DecisionUnknown

Device Summary

EsoCheck CCD Cell Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Lucid Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K183262. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EsoCheck CCD Cell Collection Device?

EsoCheck CCD Cell Collection Device is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Lucid Diagnostics, Inc.. The 510(k) number is K183262.

When did EsoCheck CCD Cell Collection Device receive FDA 510(k) clearance?

EsoCheck CCD Cell Collection Device received FDA 510(k) clearance on 2019-06-21, under 510(k) number K183262.

Who is the listed applicant for EsoCheck CCD Cell Collection Device?

The FDA 510(k) record lists Lucid Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EsoCheck CCD Cell Collection Device?

The FDA product code for EsoCheck CCD Cell Collection Device is EOX.

Other records listing Lucid Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230339EsoCheck Cell Collection DeviceK222366EsoCheck Cell Collection DeviceK210137EsoCheck Cell Collection Device

Related Devices (Code: EOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑