Device Classification Name |
System, Automated Platelet Aggregation
|
510(k) Number |
K760893 |
Device Name |
AGGRECETIN |
Applicant |
BIO/DATA CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIO/DATA CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.5700
|
Classification Product Code |
|
Date Received | 10/27/1976 |
Decision Date | 01/12/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|