Device Classification Name |
controls for blood-gases, (assayed and unassayed)
|
510(k) Number |
K150226 |
Device Name |
Hematocrit and Metabolite QUALICHECK |
Applicant |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
|
|
Applicant Contact |
Mette Skytte Harpsoee |
Correspondent |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
|
|
Correspondent Contact |
Mette Skytte Harpsoee |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 02/02/2015 |
Decision Date | 05/13/2015 |
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
|
|
|