Device Classification Name |
system, multipurpose for in vitro coagulation studies
|
510(k) Number |
K082675 |
Device Name |
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER |
Applicant |
DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
UMBERTO V PARROTTA |
Correspondent |
DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
UMBERTO V PARROTTA |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 09/15/2008 |
Decision Date | 10/10/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|