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)

THE CHEN MEDIUM

K-Number: K954548 · 1996-05-20

ApplicantChen Ophthalmic Laboratories
Decision Date1996-05-20
Product CodeLYX
DecisionSubstantially Equivalent

Device Summary

THE CHEN MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Chen Ophthalmic Laboratories. It received FDA 510(k) clearance on 1996-05-20 under 510(k) number K954548. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CHEN MEDIUM?

THE CHEN MEDIUM is a medical device that received FDA 510(k) clearance on 1996-05-20. The listed applicant is Chen Ophthalmic Laboratories. The 510(k) number is K954548.

When did THE CHEN MEDIUM receive FDA 510(k) clearance?

THE CHEN MEDIUM received FDA 510(k) clearance on 1996-05-20, under 510(k) number K954548.

Who is the listed applicant for THE CHEN MEDIUM?

The FDA 510(k) record lists Chen Ophthalmic Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE CHEN MEDIUM?

The FDA product code for THE CHEN MEDIUM is LYX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LYX)

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.

K251320XTRA4Al.Chi.Mi.A. S.R.LK221759CornisolAurolabK211786Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, IncorporatedK162013Eusol-CAl.Chi.Mi.A. S.R.LK063304LIFE4CNumedis, Inc.K063617EUSOL-CAl.Chi.Mi.A

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.

↑