The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Aqt90 Flex Myo Test Kit, Aqt90 Flex Ckmb Test Kit, Aqt90 Flex.
| Device ID | K163462 |
| 510k Number | K163462 |
| Device Name: | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | Radiometer Medical ApS Aakandevej 21 Broenshoej, DK 2700 |
| Contact | Per Pape Thomsen |
| Correspondent | Per Pape Thomsen Radiometer Medical ApS Aakandevej 21 Broenshoej, DK 2700 |
| Product Code | JHX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | KHO |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-09-21 |
| Summary: | summary |