BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS

Calibrators, Drug Mixture

BAYER DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Valproic Acid Assay For The Acs:180 And Advia Centaur Analyzers.

Pre-market Notification Details

Device IDK013959
510k NumberK013959
Device Name:BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
ClassificationCalibrators, Drug Mixture
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 CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-30
Decision Date2002-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414527369 K013959 000
00630414527352 K013959 000
00630414527345 K013959 000
00630414527338 K013959 000
00630414527321 K013959 000

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