Automated Differential Cell Counter

Counter, Differential Cell

Becton Dickinson Immunocytometry Systems

The following data is part of a premarket notification filed by Becton Dickinson Immunocytometry Systems with the FDA for Automated Differential Cell Counter.

Pre-market Notification Details

Device IDBK970046
510k NumberBK970046
Device Name:Automated Differential Cell Counter
ClassificationCounter, Differential Cell
Applicant Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose,  CA  95131
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-22
Decision Date1998-08-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903405237 BK970046 000

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