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FDA 510(k)

HEMOTEC HEPCON/SYSTEM FOUR & FOUR P

K-Number: K820410 · 1982-04-09

ApplicantHemotec, Inc.
Decision Date1982-04-09
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMOTEC HEPCON/SYSTEM FOUR & FOUR 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 1982-04-09 under 510(k) number K820410. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOTEC HEPCON/SYSTEM FOUR & FOUR P?

HEMOTEC HEPCON/SYSTEM FOUR & FOUR P is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Hemotec, Inc.. The 510(k) number is K820410.

When did HEMOTEC HEPCON/SYSTEM FOUR & FOUR P receive FDA 510(k) clearance?

HEMOTEC HEPCON/SYSTEM FOUR & FOUR P received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820410.

Who is the listed applicant for HEMOTEC HEPCON/SYSTEM FOUR & FOUR 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 HEMOTEC HEPCON/SYSTEM FOUR & FOUR P?

The FDA product code for HEMOTEC HEPCON/SYSTEM FOUR & FOUR P is LOX.

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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: LOX)

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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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