ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3

Enzyme Controls (assayed And Unassayed)

BAYER HEALTHCARE, LLC

The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Centaur And Acs:180 Liquid Cardiac Markers 1, 2, 3.

Pre-market Notification Details

Device IDK030102
510k NumberK030102
Device Name:ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactKenneth T Edds
CorrespondentKenneth T Edds
BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-10
Decision Date2003-01-24
Summary:summary

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