Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K940432 |
Device Name |
MICROCOAGULATION PROTHROMBIN TIME TEST |
Applicant |
INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. |
EDISON,
NJ
08820
|
|
Applicant Contact |
ROBERT N BORGHESE |
Correspondent |
INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. |
EDISON,
NJ
08820
|
|
Correspondent Contact |
ROBERT N BORGHESE |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 01/31/1994 |
Decision Date | 05/18/1994 |
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
|
|
|