FDA 510(k)

HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

K-Number: K010193 · 2001-06-06

Decision Date2001-06-06

Product CodeKFF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K010193. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS?

HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is International Technidyne Corp.. The 510(k) number is K010193.

When did HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS receive FDA 510(k) clearance?

HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS received FDA 510(k) clearance on 2001-06-06, under 510(k) number K010193.

Who is the listed applicant for HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS?

The FDA 510(k) record lists International Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS?

The FDA product code for HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS is KFF.

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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.