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)

DUET SYSTEM

K-Number: K030192 · 2003-08-20

ApplicantBioview , Ltd.
Decision Date2003-08-20
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DUET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioview , Ltd.. It received FDA 510(k) clearance on 2003-08-20 under 510(k) number K030192. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUET SYSTEM?

DUET SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Bioview , Ltd.. The 510(k) number is K030192.

When did DUET SYSTEM receive FDA 510(k) clearance?

DUET SYSTEM received FDA 510(k) clearance on 2003-08-20, under 510(k) number K030192.

Who is the listed applicant for DUET SYSTEM?

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

What is the FDA product code for DUET SYSTEM?

The FDA product code for DUET SYSTEM is JOY.

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 Bioview , Ltd. 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.

K061602DUET SYSTEMK050840MODIFICATION TO DUET SYSTEMK040591DUET SYSTEM

Related Devices (Code: JOY)

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.

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, 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.

↑