Device Classification Name |
system, multipurpose for in vitro coagulation studies
|
510(k) Number |
K993678 |
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 | 11/01/1999 |
Decision Date | 05/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|