Device Classification Name |
bilirubin (total and unbound) in the neonate test system
|
510(k) Number |
K170882 |
Device Name |
ABL90 FLEX, ABL90 FLEX PLUS |
Applicant |
Radiometer Medical ApS |
Aakandevej 21 |
Broenshoej,
DK
DK-2700
|
|
Applicant Contact |
Soren Boegestrand |
Correspondent |
Radiometer Medical ApS |
Aakandevej 21 |
Broenshoej,
DK
DK-2700
|
|
Correspondent Contact |
Soren Bogestrand |
Regulation Number | 862.1113
|
Classification Product Code |
|
Date Received | 03/24/2017 |
Decision Date | 04/28/2017 |
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
|
|
|