The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl90 Flex, Abl90 Flex Plus.
| Device ID | K170882 |
| 510k Number | K170882 |
| Device Name: | ABL90 FLEX, ABL90 FLEX PLUS |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | Radiometer Medical ApS Aakandevej 21 Broenshoej, DK Dk-2700 |
| Contact | Soren Boegestrand |
| Correspondent | Soren Bogestrand Radiometer Medical ApS Aakandevej 21 Broenshoej, DK Dk-2700 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-24 |
| Decision Date | 2017-04-28 |
| Summary: | summary |