Device Classification Name |
test, time, partial thromboplastin
|
510(k) Number |
K863594 |
Device Name |
ACTIN FSL ACTIVATED PTT REAGENT |
Applicant |
AMERICAN DADE |
P.O. BOX 25101 |
SANTA ANA,
CA
92799
|
|
Applicant Contact |
KAREN H DARCY |
Correspondent |
AMERICAN DADE |
P.O. BOX 25101 |
SANTA ANA,
CA
92799
|
|
Correspondent Contact |
KAREN H DARCY |
Regulation Number | 864.7925
|
Classification Product Code |
|
Date Received | 09/15/1986 |
Decision Date | 10/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|