Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K974566 |
Device Name |
MDA SIMPLASTIN HTF |
Applicant |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Applicant Contact |
REBECCA A RIVAS |
Correspondent |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Correspondent Contact |
REBECCA A RIVAS |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 12/05/1997 |
Decision Date | 02/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|