ADVIA TESTPOINT CSF CONTROL

Mixture, Hematology Quality Control

BAYER DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia Testpoint Csf Control.

Pre-market Notification Details

Device IDK022968
510k NumberK022968
Device Name:ADVIA TESTPOINT CSF CONTROL
ClassificationMixture, Hematology Quality Control
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 CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-06
Decision Date2002-09-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414472539 K022968 000

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