ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD

Counter, Cell, Automated (particle Counter)

BAYER DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia 120 Hematology System, Cerebrospinal Fluid Method.

Pre-market Notification Details

Device IDK022331
510k NumberK022331
Device Name:ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
ClassificationCounter, Cell, Automated (particle Counter)
Applicant BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactKenneth T Edds
CorrespondentKenneth T Edds
BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeGKL  
Subsequent Product CodeGKZ
Subsequent Product CodeJPK
CFR Regulation Number864.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-18
Decision Date2002-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414473444 K022331 000

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