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 |