Device Classification Name |
Instrument, Coagulation, Automated
|
510(k) Number |
K001645 |
Device Name |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
Applicant |
DADE BEHRING, INC. |
7739 NW 48 ST. |
SUITE 120 |
MIAMI,
FL
33166
|
|
Applicant Contact |
RADAMES RIESGO |
Correspondent |
DADE BEHRING, INC. |
7739 NW 48 ST. |
SUITE 120 |
MIAMI,
FL
33166
|
|
Correspondent Contact |
RADAMES RIESGO |
Regulation Number | 864.5400
|
Classification Product Code |
|
Date Received | 05/30/2000 |
Decision Date | 08/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|