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FDA 510(k)

HITT BY HEMOCHRON(R)

K-Number: K910181 · 1991-05-10

ApplicantInternational Technidyne Corp.
Decision Date1991-05-10
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HITT BY HEMOCHRON(R) 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 1991-05-10 under 510(k) number K910181. 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 HITT BY HEMOCHRON(R)?

HITT BY HEMOCHRON(R) is a medical device that received FDA 510(k) clearance on 1991-05-10. The listed applicant is International Technidyne Corp.. The 510(k) number is K910181.

When did HITT BY HEMOCHRON(R) receive FDA 510(k) clearance?

HITT BY HEMOCHRON(R) received FDA 510(k) clearance on 1991-05-10, under 510(k) number K910181.

Who is the listed applicant for HITT BY HEMOCHRON(R)?

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 HITT BY HEMOCHRON(R)?

The FDA product code for HITT BY HEMOCHRON(R) is KFF.

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Other records listing International Technidyne Corp. as applicant

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Related Devices (Code: KFF)

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K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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