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FDA 510(k)

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II

K-Number: K944691 · 1995-03-15

ApplicantInternational Technidyne Corp.
Decision Date1995-03-15
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II 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 1995-03-15 under 510(k) number K944691. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II?

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II is a medical device that received FDA 510(k) clearance on 1995-03-15. The listed applicant is International Technidyne Corp.. The 510(k) number is K944691.

When did ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II receive FDA 510(k) clearance?

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II received FDA 510(k) clearance on 1995-03-15, under 510(k) number K944691.

Who is the listed applicant for ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II?

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 WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II?

The FDA product code for ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II is GGN.

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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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