Device Classification Name |
test, erythrocyte sedimentation rate
|
510(k) Number |
K823368 |
Device Name |
DADE ESR KIT |
Applicant |
AMERICAN DADE |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN DADE |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.6700
|
Classification Product Code |
|
Date Received | 11/10/1982 |
Decision Date | 12/28/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|