The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Safepico.
| Device ID | K043143 |
| 510k Number | K043143 |
| Device Name: | SAFEPICO |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Lene Meineche Marnaes |
| Correspondent | Lene Meineche Marnaes RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-04-22 |
| Summary: | summary |