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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2024 | ACTIM OY Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane Open, Classified |
OAM | K123986 |
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