Device Classification Name |
System, Multipurpose For In Vitro Coagulation Studies
|
510(k) Number |
K002177 |
Device Name |
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES |
Applicant |
HAEMOSCOPE CORP. |
7855 GROSS POINT RD. |
SUITE G4 |
SKOKIE,
IL
60077
|
|
Applicant Contact |
ELI COHEN |
Correspondent |
HAEMOSCOPE CORP. |
7855 GROSS POINT RD. |
SUITE G4 |
SKOKIE,
IL
60077
|
|
Correspondent Contact |
ELI COHEN |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 07/19/2000 |
Decision Date | 09/14/2000 |
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
|
|
|