Device Classification Name |
prothrombin fragment 1.2
|
510(k) Number |
K964934 |
Device Name |
THROMBONOSTIKA F1.2 |
Applicant |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Applicant Contact |
RON SANYAL |
Correspondent |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Correspondent Contact |
RON SANYAL |
Regulation Number | 864.7320
|
Classification Product Code |
|
Date Received | 12/09/1996 |
Decision Date | 03/18/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|