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)

ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4

K-Number: K050768 · 2005-04-28

ApplicantHamilton Thorne Biosciences
Decision Date2005-04-28
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Biosciences. It received FDA 510(k) clearance on 2005-04-28 under 510(k) number K050768. The device is classified under product code MRX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4?

ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 is a medical device that received FDA 510(k) clearance on 2005-04-28. The listed applicant is Hamilton Thorne Biosciences. The 510(k) number is K050768.

When did ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 receive FDA 510(k) clearance?

ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 received FDA 510(k) clearance on 2005-04-28, under 510(k) number K050768.

Who is the listed applicant for ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4?

The FDA 510(k) record lists Hamilton Thorne Biosciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4?

The FDA product code for ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 is MRX.

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

Other records listing Hamilton Thorne Biosciences 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.

K063636ZILOS-TK

Related Devices (Code: MRX)

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.

K253333Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd.K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)Hamilton Thorne, Inc.K192008LaserShot M, NaviLaseVitrolife GmbHK120055HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOSHamilton Thorne, Inc.K083208SATURN ACTIVE LASER SYSTEMResearch Instruments , Ltd.K063636ZILOS-TKHamilton Thorne Biosciences

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.

↑