Device Classification Name |
System, Multipurpose For In Vitro Coagulation Studies
|
510(k) Number |
K030818 |
Device Name |
HEMOCHRON RESPONSE/SYSTEM |
Applicant |
INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. |
EDISON,
NJ
08820
|
|
Applicant Contact |
JOHN CLAY |
Correspondent |
INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. |
EDISON,
NJ
08820
|
|
Correspondent Contact |
JOHN CLAY |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 03/14/2003 |
Decision Date | 04/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|