SAFEPICO
FDA 510(k) clearance K043143 · decided 2005-04-22
Clearance details
- K-number
- K043143
- Device name
- SAFEPICO
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2004-11-15
- Decision date
- 2005-04-22
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bronshoj, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are in recall (Z-1443-06) | Radiometer America Inc | 2006-08-29 |