Device Classification Name |
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
|
510(k) Number |
K002215 |
Device Name |
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA |
Applicant |
COGENT DIAGNOTICS LTD. |
BUSH LOAN |
PENICUIK |
MIDLOTHIAN EH26 0PL,
GB
EH26 OPL
|
|
Applicant Contact |
DANIELLE M KNIGHT |
Correspondent |
COGENT DIAGNOTICS LTD. |
BUSH LOAN |
PENICUIK |
MIDLOTHIAN EH26 0PL,
GB
EH26 OPL
|
|
Correspondent Contact |
DANIELLE M KNIGHT |
Regulation Number | 866.5660
|
Classification Product Code |
|
Date Received | 07/24/2000 |
Decision Date | 09/28/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|