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FDA 510(k)

HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II

K-Number: K882480 · 1988-08-30

ApplicantInternational Technidyne Corp.
Decision Date1988-08-30
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/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 1988-08-30 under 510(k) number K882480. 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 HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II?

HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is International Technidyne Corp.. The 510(k) number is K882480.

When did HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II receive FDA 510(k) clearance?

HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II received FDA 510(k) clearance on 1988-08-30, under 510(k) number K882480.

Who is the listed applicant for HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/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 HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II?

The FDA product code for HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/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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