Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K882214 |
Device Name |
SIMPLASTIN EXCEL S |
Applicant |
ORGANON TEKNIKA CORP. |
800 CAPITOLA DR. |
DURHAM,
NC
27713
|
|
Applicant Contact |
TONI M STIFANO |
Correspondent |
ORGANON TEKNIKA CORP. |
800 CAPITOLA DR. |
DURHAM,
NC
27713
|
|
Correspondent Contact |
TONI M STIFANO |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 05/26/1988 |
Decision Date | 07/01/1988 |
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
|
|
|