ABBOTT CELL-DYN 3200 SYSTEM

Counter, Differential Cell

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Cell-dyn 3200 System.

Pre-market Notification Details

Device IDK972354
510k NumberK972354
Device Name:ABBOTT CELL-DYN 3200 SYSTEM
ClassificationCounter, Differential Cell
Applicant ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
ContactSue E Luptovic
CorrespondentSue E Luptovic
ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-24
Decision Date1997-09-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740007317 K972354 000
00380740007300 K972354 000
00380740007270 K972354 000
00380740007263 K972354 000

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