Counter, Differential Cell

Counter, Differential Cell

Sysmex America, Inc.

The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Counter, Differential Cell.

Pre-market Notification Details

Device IDBK210559
510k NumberBK210559
Device Name:Counter, Differential Cell
ClassificationCounter, Differential Cell
Applicant Sysmex America, Inc. 577 Aptakisic Rd Lincolnshire,  IL  60069
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-04
Decision Date2021-05-27

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