Automated Differential Cell Counter

Counter, Differential Cell

R & D Systems, Inc

The following data is part of a premarket notification filed by R & D Systems, Inc with the FDA for Automated Differential Cell Counter.

Pre-market Notification Details

Device IDBK000035
510k NumberBK000035
Device Name:Automated Differential Cell Counter
ClassificationCounter, Differential Cell
Applicant R & D Systems, Inc 614 Mckinley Place N.e. Minneapolis,  MN  55413 US
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-31
Decision Date2000-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590639396 BK000035 0
00382903410033 BK000035 000
00382903410019 BK000035 000

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