The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Aqt90 Flex Analyzer, Aqt90 Flex Myoglobin Test Kit, Aqt90 Flex Lqc Multi-check, Lvls 1-3, Aqt90 Flex Myo Cal Cartridge...
| Device ID | K112161 |
| 510k Number | K112161 |
| Device Name: | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. |
| Classification | Fluorometer, For Clinical Use |
| Applicant | RADIOMETER MEDICAL APS AAKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Jana S Hellmann |
| Correspondent | Jana S Hellmann RADIOMETER MEDICAL APS AAKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | KHO |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-27 |
| Decision Date | 2012-01-20 |
| Summary: | summary |