Device Classification Name |
diazo colorimetry, bilirubin
|
510(k) Number |
K223324 |
Device Name |
Total Bilirubin2 |
Applicant |
Abbott Ireland Diagnostics Division |
Lisnarnuck |
Longford,
IE
|
|
Applicant Contact |
Magdalena Suszko |
Correspondent |
Abbott Ireland Diagnostics Division |
Lisnarnuck |
Longford,
IE
|
|
Correspondent Contact |
Magdalena Suszko |
Regulation Number | 862.1110
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/31/2022 |
Decision Date | 12/29/2022 |
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
|
|
|