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FDA 510(k)

HEMOCHRON RESPONSE/SYSTEM

K-Number: K030818 · 2003-04-02

ApplicantInternational Technidyne Corp.
Decision Date2003-04-02
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON RESPONSE/SYSTEM 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 2003-04-02 under 510(k) number K030818. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON RESPONSE/SYSTEM?

HEMOCHRON RESPONSE/SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-02. The listed applicant is International Technidyne Corp.. The 510(k) number is K030818.

When did HEMOCHRON RESPONSE/SYSTEM receive FDA 510(k) clearance?

HEMOCHRON RESPONSE/SYSTEM received FDA 510(k) clearance on 2003-04-02, under 510(k) number K030818.

Who is the listed applicant for HEMOCHRON RESPONSE/SYSTEM?

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 RESPONSE/SYSTEM?

The FDA product code for HEMOCHRON RESPONSE/SYSTEM is JPA.

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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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