Device Classification Name |
aggregrometer, platelet
|
510(k) Number |
K760159 |
Device Name |
AGGREGOMETER, DUAL CHANNEL PLATELET |
Applicant |
CHRONO-LOG CORP. |
2 WEST PARK RD. |
HAVERTOWN,
PA
19083
|
|
Applicant Contact |
Arthur Freilich |
Correspondent |
CHRONO-LOG CORP. |
2 WEST PARK RD. |
HAVERTOWN,
PA
19083
|
|
Correspondent Contact |
Arthur Freilich |
Regulation Number | 864.6675
|
Classification Product Code |
|
Date Received | 07/02/1976 |
Decision Date | 07/20/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|