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FDA 510(k)

HEPARIN ASSAY CARTRIDGES AND CONTROLS

K-Number: K944115 · 1995-03-24

ApplicantMedtronic Hemotec, Inc.
Decision Date1995-03-24
Product CodeGFT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPARIN ASSAY CARTRIDGES AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Hemotec, Inc.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K944115. The device is classified under product code GFT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPARIN ASSAY CARTRIDGES AND CONTROLS?

HEPARIN ASSAY CARTRIDGES AND CONTROLS is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Medtronic Hemotec, Inc.. The 510(k) number is K944115.

When did HEPARIN ASSAY CARTRIDGES AND CONTROLS receive FDA 510(k) clearance?

HEPARIN ASSAY CARTRIDGES AND CONTROLS received FDA 510(k) clearance on 1995-03-24, under 510(k) number K944115.

Who is the listed applicant for HEPARIN ASSAY CARTRIDGES AND CONTROLS?

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

What is the FDA product code for HEPARIN ASSAY CARTRIDGES AND CONTROLS?

The FDA product code for HEPARIN ASSAY CARTRIDGES AND CONTROLS is GFT.

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.

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Other records listing Medtronic 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.

K954202PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMSK940426MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERK923594CLOTTRAC COAGULATION CONTROLK922031HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL

Related Devices (Code: GFT)

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.

K910105PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200International Technidyne Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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