Device Classification Name |
centrifuges (micro, ultra, refrigerated) for clinical use
|
510(k) Number |
K024080 |
Device Name |
SECQUIRE CELL SEPARATOR |
Applicant |
PERFUSION PARTNERS & ASSOC. INC. |
P.O. BOX 4341 |
crofton,
MD
21114
|
|
Applicant Contact |
e.j. smith |
Correspondent |
PERFUSION PARTNERS & ASSOC. INC. |
P.O. BOX 4341 |
crofton,
MD
21114
|
|
Correspondent Contact |
e.j. smith |
Regulation Number | 862.2050
|
Classification Product Code |
|
Date Received | 12/10/2002 |
Decision Date | 07/02/2003 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|