Device Classification Name |
Igm, Antigen, Antiserum, Control
|
510(k) Number |
K760147 |
Device Name |
SERUM, IGM ANTI-HUMAN ACID |
Applicant |
OXFORD LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
OXFORD LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 866.5550
|
Classification Product Code |
|
Date Received | 06/29/1976 |
Decision Date | 07/20/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|