The following data is part of a premarket notification filed by Alere Scarborough, Inc with the FDA for Actim Prom.
| Device ID | K123986 |
| 510k Number | K123986 |
| Device Name: | ACTIM PROM |
| Classification | Immunoassay, Insulin-like Growth Factor Binding Protein-1 |
| Applicant | ALERE SCARBOROUGH, INC 10 Southgate Road Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale ALERE SCARBOROUGH, INC 10 Southgate Road Scarborough, ME 04074 |
| Product Code | OAM |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2014-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430030990615 | K123986 | 000 |
| 06430030990622 | K123986 | 000 |