FDA 510(k)

CC-700 SEVEN PARAMETER, AUTOMATED HEMAA

K-Number: K821238 · 1982-05-28

ApplicantDysmex

Decision Date1982-05-28

Product CodeGKL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CC-700 SEVEN PARAMETER, AUTOMATED HEMAA is the device name listed in this FDA 510(k) record. The listed applicant is Dysmex. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821238. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CC-700 SEVEN PARAMETER, AUTOMATED HEMAA?

CC-700 SEVEN PARAMETER, AUTOMATED HEMAA is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Dysmex. The 510(k) number is K821238.

When did CC-700 SEVEN PARAMETER, AUTOMATED HEMAA receive FDA 510(k) clearance?

CC-700 SEVEN PARAMETER, AUTOMATED HEMAA received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821238.

Who is the listed applicant for CC-700 SEVEN PARAMETER, AUTOMATED HEMAA?

The FDA 510(k) record lists Dysmex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CC-700 SEVEN PARAMETER, AUTOMATED HEMAA?

The FDA product code for CC-700 SEVEN PARAMETER, AUTOMATED HEMAA is GKL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.