ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR

Calibrator, Secondary

BAYER DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia Centaur And Acs:180 C-peptide Calibrator.

Pre-market Notification Details

Device IDK021532
510k NumberK021532
Device Name:ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
ClassificationCalibrator, Secondary
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 CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-10
Decision Date2002-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414600420 K021532 000
00630414464008 K021532 000

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