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FDA 510(k)

HEPCOL SYSTEM B-10 & B-10-P

K-Number: K830665 · 1983-06-08

ApplicantHemotec, Inc.
Decision Date1983-06-08
Product CodeJOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPCOL SYSTEM B-10 & B-10-P is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830665. 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 HEPCOL SYSTEM B-10 & B-10-P?

HEPCOL SYSTEM B-10 & B-10-P is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Hemotec, Inc.. The 510(k) number is K830665.

When did HEPCOL SYSTEM B-10 & B-10-P receive FDA 510(k) clearance?

HEPCOL SYSTEM B-10 & B-10-P received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830665.

Who is the listed applicant for HEPCOL SYSTEM B-10 & B-10-P?

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 HEPCOL SYSTEM B-10 & B-10-P?

The FDA product code for HEPCOL SYSTEM B-10 & B-10-P is JOX.

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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: 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.

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