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)

HEMOCHRON SIGNATURE ELITE

K-Number: K050016 · 2005-02-10

ApplicantInternational Technidyne Corp.
Decision Date2005-02-10
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON SIGNATURE ELITE is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 2005-02-10 under 510(k) number K050016. 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 HEMOCHRON SIGNATURE ELITE?

HEMOCHRON SIGNATURE ELITE is a medical device that received FDA 510(k) clearance on 2005-02-10. The listed applicant is International Technidyne Corp.. The 510(k) number is K050016.

When did HEMOCHRON SIGNATURE ELITE receive FDA 510(k) clearance?

HEMOCHRON SIGNATURE ELITE received FDA 510(k) clearance on 2005-02-10, under 510(k) number K050016.

Who is the listed applicant for HEMOCHRON SIGNATURE ELITE?

The FDA 510(k) record lists International Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOCHRON SIGNATURE ELITE?

The FDA product code for HEMOCHRON SIGNATURE ELITE 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 International Technidyne Corp. 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.

K120977DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MICK030818HEMOCHRON RESPONSE/SYSTEMK023561ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEMK020798HEMOCHRON JR. SIGNATURE +K010599PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTEK010193HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

View all 47 devices →

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.

↑