Device Classification Name |
Fluorometric Method, Cpk Or Isoenzymes
|
510(k) Number |
K120326 |
Device Name |
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE |
Applicant |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Applicant Contact |
OLE SCHOU |
Correspondent |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Correspondent Contact |
OLE SCHOU |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/02/2012 |
Decision Date | 11/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|