BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611

Counter, Differential Cell

BD Biosciences

The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Bd Multitest 6-color Tbnk Reagent, Model 644611.

Pre-market Notification Details

Device IDK090967
510k NumberK090967
Device Name:BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
ClassificationCounter, Differential Cell
Applicant BD Biosciences 2350 QUME DR. San Jose,  CA  95131 -1807
ContactKaty Campbell
CorrespondentKaty Campbell
BD Biosciences 2350 QUME DR. San Jose,  CA  95131 -1807
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-06
Decision Date2009-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382906629678 K090967 000
00382906446114 K090967 000
00382903403349 K090967 000

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