DIGITAL-9 KEY LEUCOCYTE COUNTER

K854685 · Future Impex Corp. · GKM · Apr 4, 1986 · Hematology

Device Facts

Record IDK854685
Device NameDIGITAL-9 KEY LEUCOCYTE COUNTER
ApplicantFuture Impex Corp.
Product CodeGKM · Hematology
Decision DateApr 4, 1986
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 864.6160
Device ClassClass 1

Regulatory Classification

Identification

A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

Innolitics

Panel 1

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