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FDA 510(k)

ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM

K-Number: K923761 · 1993-01-21

ApplicantInternational Technidyne Corp.
Decision Date1993-01-21
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ITC MICROSAMPLE COAGULATION ANALYZER 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 1993-01-21 under 510(k) number K923761. 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 ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM?

ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is International Technidyne Corp.. The 510(k) number is K923761.

When did ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM receive FDA 510(k) clearance?

ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM received FDA 510(k) clearance on 1993-01-21, under 510(k) number K923761.

Who is the listed applicant for ITC MICROSAMPLE COAGULATION ANALYZER 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 ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM?

The FDA product code for ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM is JPA.

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Related Devices (Code: 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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