QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM

Counter, Differential Cell

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Qbc Star Centrifugal Hematology System.

Pre-market Notification Details

Device IDK992849
510k NumberK992849
Device Name:QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
ClassificationCounter, Differential Cell
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
ContactMonica E Giguere
CorrespondentMonica E Giguere
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-24
Decision Date1999-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858092006727 K992849 000
00858092006017 K992849 000
00858092006055 K992849 000
00858092006291 K992849 000
00858092006376 K992849 000
00858092006550 K992849 000
00858092006567 K992849 000
00858092006628 K992849 000
00858092006642 K992849 000
00858092006659 K992849 000
00858092006710 K992849 000
00858092006000 K992849 000

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