FDA 510(k) Applications for Medical Device Product Code "MYT"
(Biosensor, Immunoassay, Cpk Or Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K033155 BIOCENTREX BIOCENTREX CARDIAC PANEL 01/12/2004
K051433 I-STAT CORPORATION I-STAT CREATINE KINASE MB (CK-MB) 12/15/2005
K984433 QUANTECH LTD. QUANTECH CK-MB ASSAY 11/01/1999


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