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)

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS

K-Number: K854377 · 1985-12-04

ApplicantHemotec, Inc.
Decision Date1985-12-04
Product CodeJOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1985-12-04 under 510(k) number K854377. The device is classified under product code JOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS?

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS is a medical device that received FDA 510(k) clearance on 1985-12-04. The listed applicant is Hemotec, Inc.. The 510(k) number is K854377.

When did HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS receive FDA 510(k) clearance?

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS received FDA 510(k) clearance on 1985-12-04, under 510(k) number K854377.

Who is the listed applicant for HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS?

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

What is the FDA product code for HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS?

The FDA product code for HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS is JOX.

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 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.

K902081CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROLK894359CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLSK894317HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.K894466HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLSK884590HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGESK875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN

View all 15 devices →

Related Devices (Code: JOX)

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.

K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.K102953HEPARIN DOSE RESPONSE CARTRIDGEMedtronic, Inc.K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XXMedtronic, Inc.K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Perfusion SystemsK043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic VascularK042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20Medtronic Vascular

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.

↑