ACTIM PROM AND CONTROLS
FDA 510(k) clearance K061886 · decided 2007-01-25
Clearance details
- K-number
- K061886
- Device name
- ACTIM PROM AND CONTROLS
- Applicant
- Medix Biochemica
- Decision
- Substantially Equivalent
- Date received
- 2006-07-03
- Decision date
- 2007-01-25
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- OAM
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- North Attleboro, MA, 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 (K123986) | Alere Scarborough, Inc. | 2014-01-09 |
Recalls involving this device
No recalls on record reference this clearance.