Device Classification Name |
abnormal hemoglobin quantitation
|
510(k) Number |
K232027 |
Device Name |
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument |
Applicant |
Sebia |
1705 Corporate Drive Suite 400 |
Norcross,
GA
30093
|
|
Applicant Contact |
Karen Anderson |
Correspondent |
Sebia |
1705 Corporate Drive Suite 400 |
Norcross,
GA
30093
|
|
Correspondent Contact |
Karen Anderson |
Regulation Number | 864.7415
|
Classification Product Code |
|
Date Received | 07/07/2023 |
Decision Date | 04/04/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|