ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

Counter, Differential Cell

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 Complete Blood Count (cbc) Method.

Pre-market Notification Details

Device IDK022668
510k NumberK022668
Device Name:ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
ClassificationCounter, Differential Cell
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 CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-12
Decision Date2002-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414558400 K022668 000

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