510(k) K123986
- Device
- ACTIM PROM
- Applicant
- ALERE SCARBOROUGH, INC
- 510(k) number
- K123986
- Product code
- OAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-09
- Date received
- 2012-12-26
- Regulation
- 862.1550
- Classification name
- Immunoassay, Insulin-like Growth Factor Binding Protein-1
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Angela Drysdale
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 3009335633
- 3005360469
- 1000212994
- 3031915160
- 3012526002
- 3016837106
- 3024463179
- 8021924
- 2029372
- 3013143953
- 3016733849
- 3007118747
Source Documents#
Other 510(k) Records For Product Code OAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061886 | ACTIM PROM AND CONTROLS | Medix Biochemica | 2007-01-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary