DILUENT, CELLENT BLOOD

Diluent, Blood Cell

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Diluent, Cellent Blood.

Pre-market Notification Details

Device IDK790028
510k NumberK790028
Device Name:DILUENT, CELLENT BLOOD
ClassificationDiluent, Blood Cell
Applicant SYSMEX CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGIF  
CFR Regulation Number864.8200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-03
Decision Date1979-02-15

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