The following data is part of a premarket notification filed by Medix Biochemica with the FDA for Actim Prom And Controls.
| Device ID | K061886 |
| 510k Number | K061886 |
| Device Name: | ACTIM PROM AND CONTROLS |
| Classification | Immunoassay, Insulin-like Growth Factor Binding Protein-1 |
| Applicant | MEDIX BIOCHEMICA 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia Sinclair |
| Correspondent | Cynthia Sinclair MEDIX BIOCHEMICA 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | OAM |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2007-01-25 |
| Summary: | summary |