Device Classification Name |
activated partial thromboplastin
|
510(k) Number |
K972831 |
Device Name |
HEMOCHRON CITRATE APTT |
Applicant |
INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. |
EDISON,
NJ
08820
|
|
Applicant Contact |
ROBERT H MATLAND |
Correspondent |
INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. |
EDISON,
NJ
08820
|
|
Correspondent Contact |
ROBERT H MATLAND |
Regulation Number | 864.7925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/30/1997 |
Decision Date | 11/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|