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FDA 510(k)

ZILOS-TK

K-Number: K063636 · 2007-04-24

ApplicantHamilton Thorne Biosciences
Decision Date2007-04-24
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ZILOS-TK 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 2007-04-24 under 510(k) number K063636. 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?

ZILOS-TK is a medical device that received FDA 510(k) clearance on 2007-04-24. The listed applicant is Hamilton Thorne Biosciences. The 510(k) number is K063636.

When did ZILOS-TK receive FDA 510(k) clearance?

ZILOS-TK received FDA 510(k) clearance on 2007-04-24, under 510(k) number K063636.

Who is the listed applicant for ZILOS-TK?

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?

The FDA product code for ZILOS-TK 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.

K050768ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4

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.K060764SATURN 3 LASER SYSTEMResearch Instruments , Ltd.

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.

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