MYT · Class II · 21 CFR 862.1215

FDA Product Code MYT: Biosensor, Immunoassay, Cpk Or Isoenzymes

Leading manufacturers include Biocentrex, I-Stat Corporation and Quantech , Ltd..

3
Total
3
Cleared
208d
Avg days
1999
Since

FDA 510(k) Cleared Biosensor, Immunoassay, Cpk Or Isoenzymes Devices (Product Code MYT)

3 devices
1–3 of 3
Cleared Dec 15, 2005
I-STAT CREATINE KINASE MB (CK-MB)
K051433
I-Stat Corporation
Chemistry · 197d
Cleared Jan 12, 2004
BIOCENTREX CARDIAC PANEL
K033155
Biocentrex
Chemistry · 104d
Cleared Nov 01, 1999
QUANTECH CK-MB ASSAY
K984433
Quantech , Ltd.
Chemistry · 322d

About Product Code MYT - Regulatory Context