Device Classification Name |
lynch syndrome test system
|
510(k) Number |
K213348 |
Device Name |
BOND MMR Antibody Panel |
Applicant |
Leica Biosystems Newcastle, Ltd. |
Balliol Business Park West, Benton Lane |
Newcastle Upon Tyne,
GB
NE12 8EW
|
|
Applicant Contact |
Kristin Godfredsen |
Correspondent |
Leica Biosystems Newcastle, Ltd. |
Balliol Business Park West, Benton Lane |
Newcastle Upon Tyne,
GB
NE12 8EW
|
|
Correspondent Contact |
Christine Kishi |
Regulation Number | 864.1866
|
Classification Product Code |
|
Date Received | 10/08/2021 |
Decision Date | 02/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|