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FDA 510(k)

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200

K-Number: K910105 · 1991-02-26

ApplicantInternational Technidyne Corp.
Decision Date1991-02-26
Product CodeGFT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 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 1991-02-26 under 510(k) number K910105. 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 PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200?

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is International Technidyne Corp.. The 510(k) number is K910105.

When did PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 receive FDA 510(k) clearance?

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 received FDA 510(k) clearance on 1991-02-26, under 510(k) number K910105.

Who is the listed applicant for PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200?

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 PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200?

The FDA product code for PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 is GFT.

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Related Devices (Code: GFT)

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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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