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 IDBK970038
510k NumberBK970038
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 Received1997-09-22
Decision Date1999-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903411580 BK970038 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.