The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl8x7 Flex.
| Device ID | K051968 |
| 510k Number | K051968 |
| Device Name: | ABL8X7 FLEX |
| Classification | Electrode, Ion Based, Enzymatic, Creatinine |
| 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 | CGL |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-20 |
| Decision Date | 2006-10-16 |
| Summary: | summary |