Device Classification Name |
reagent, platelet aggregation
|
510(k) Number |
K760198 |
Device Name |
KIT, PLATELET AGGREGATION REAGENT (#390) |
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 | 864.5700
|
Classification Product Code |
|
Date Received | 07/06/1976 |
Decision Date | 07/19/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|