Panels › Clinical Chemistry › Product code OAM · Class 1
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Regulation 862.1550
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OAM
| Company | 510(k)s | Recalls |
|---|---|---|
| ACTIM OY | 0 | 1 |
| Alere Scarborough, Inc. | 1 | 0 |
| Medix Biochemica | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2014 | K123986 | ACTIM PROM Alere Scarborough, Inc. | OAM |
| Jan 25, 2007 | K061886 | ACTIM PROM AND CONTROLS Medix Biochemica | OAM |
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