ACTIM PROM
FDA 510(k) clearance K123986 · decided 2014-01-09
Clearance details
- K-number
- K123986
- Device name
- ACTIM PROM
- Applicant
- Alere Scarborough, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2014-01-09
- Days to decision
- 379 days
- Clearance type
- Traditional
- Product code
- OAM
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACTIM PROM AND CONTROLS (K061886) | Medix Biochemica | 2007-01-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal recall (Z-1592-2024) | ACTIM OY | 2024-04-17 |