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FDA 510(k)

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR

K-Number: K853789 · 1985-10-04

ApplicantHemotec, Inc.
Decision Date1985-10-04
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853789. 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 ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR?

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Hemotec, Inc.. The 510(k) number is K853789.

When did ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR receive FDA 510(k) clearance?

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853789.

Who is the listed applicant for ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR?

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 ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR?

The FDA product code for ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR is JPA.

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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

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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.

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