Panels › Clinical Chemistry › Product code MYT · Class 2
Biosensor, Immunoassay, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MYT
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Point Of Care Inc. | 0 | 1 |
| Biocentrex | 1 | 0 |
| I-Stat Corporation | 1 | 0 |
| Quantech , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2005 | K051433 | I-STAT CREATINE KINASE MB (CK-MB) I-Stat Corporation | MYT |
| Jan 12, 2004 | K033155 | BIOCENTREX CARDIAC PANEL Biocentrex | MYT |
| Nov 1, 1999 | K984433 | QUANTECH CK-MB ASSAY Quantech , Ltd. | MYT |
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