Counter, Differential Cell

Counter, Differential Cell

Beckman Coulter, Inc.

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

Pre-market Notification Details

Device IDBK210639
510k NumberBK210639
Device Name:Counter, Differential Cell
ClassificationCounter, Differential Cell
Applicant Beckman Coulter, Inc. 11800 Sw 147 Avenue (m/c: 31-b06) Miami,  FL  33196 2500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-15
Decision Date2021-12-15

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