The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Modification To Abl800 Flex.
| Device ID | K050869 |
| 510k Number | K050869 |
| Device Name: | MODIFICATION TO ABL800 FLEX |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | RADIOMETER MEDICAL APS 1455 PENNSYLVANIA AVENUE N.W. WILLARD OFFICE BUILDING Washington, DC 20004 |
| Contact | Mark A Heller |
| Correspondent | Mark A Heller RADIOMETER MEDICAL APS 1455 PENNSYLVANIA AVENUE N.W. WILLARD OFFICE BUILDING Washington, DC 20004 |
| Product Code | CIG |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GHS |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHP |
| Subsequent Product Code | KQI |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-06 |
| Decision Date | 2005-08-11 |
| Summary: | summary |