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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat CK-MP cartridges
Abbott Point of Care Inc.
The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. C Terminated |
MYT | K051433 |
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