Device Classification Name |
Igm, Antigen, Antiserum, Control
|
510(k) Number |
K760917 |
Device Name |
LAS-R HUMAN HAPTOGLOBIN TEST |
Applicant |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 866.5550
|
Classification Product Code |
|
Date Received | 10/28/1976 |
Decision Date | 12/30/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|