Device Classification Name |
antigens, nontreponemal, all
|
510(k) Number |
K811152 |
Device Name |
DADE RPR CARD TEST |
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 | 866.3820
|
Classification Product Code |
|
Date Received | 04/27/1981 |
Decision Date | 05/15/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|