The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Aqt90 Flex Ckmb Test Kit, Aqt90 Flex Lqc Multi-check, Levels 1-3, Aqt90 Flex Ckmb Cal Cartridge.
| Device ID | K120326 |
| 510k Number | K120326 |
| Device Name: | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Ole Schou |
| Correspondent | Ole Schou RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | JHX |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-02 |
| Decision Date | 2012-11-21 |
| Summary: | summary |