QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)

Counter, Differential Cell

BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Qbc Accutube(423406)/qbc Autoread(424571).

Pre-market Notification Details

Device IDK960827
510k NumberK960827
Device Name:QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
ClassificationCounter, Differential Cell
Applicant BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
ContactRocky Ganske
CorrespondentRocky Ganske
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-29
Decision Date1996-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858092006604 K960827 000
00858092006574 K960827 000
00858092006383 K960827 000
00858092006260 K960827 000
00858092006253 K960827 000
00858092006086 K960827 000
00858092006079 K960827 000
00858092006048 K960827 000
00858092006024 K960827 000

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