Device Classification Name |
centrifuges (micro, ultra, refrigerated) for clinical use
|
510(k) Number |
K103340 |
Device Name |
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM |
Applicant |
HARVEST TECHNOLOGIES, CORP. |
40 GRISSOM RD, SUITE 100 |
PLYMOUTH,
MA
02360
|
|
Applicant Contact |
JOHN D BONASERA |
Correspondent |
HARVEST TECHNOLOGIES, CORP. |
40 GRISSOM RD, SUITE 100 |
PLYMOUTH,
MA
02360
|
|
Correspondent Contact |
JOHN D BONASERA |
Regulation Number | 862.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/15/2010 |
Decision Date | 12/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|