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)

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

K-Number: K954202 · 1996-06-20

ApplicantMedtronic Hemotec, Inc.
Decision Date1996-06-20
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Hemotec, Inc.. It received FDA 510(k) clearance on 1996-06-20 under 510(k) number K954202. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS?

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS is a medical device that received FDA 510(k) clearance on 1996-06-20. The listed applicant is Medtronic Hemotec, Inc.. The 510(k) number is K954202.

When did PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS receive FDA 510(k) clearance?

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS received FDA 510(k) clearance on 1996-06-20, under 510(k) number K954202.

Who is the listed applicant for PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS?

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

What is the FDA product code for PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS?

The FDA product code for PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS is JPA.

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 Medtronic Hemotec, 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.

K944115HEPARIN ASSAY CARTRIDGES AND CONTROLSK940426MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERK923594CLOTTRAC COAGULATION CONTROLK922031HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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.

↑