Device Classification Name |
analyzer, chemistry, centrifugal, for clinical use
|
510(k) Number |
K934592 |
Device Name |
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR |
Applicant |
ABAXIS, INC. |
1320 CHESAPEAKE TERRACE |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
RODGER J RICHEAL |
Correspondent |
ABAXIS, INC. |
1320 CHESAPEAKE TERRACE |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
RODGER J RICHEAL |
Regulation Number | 862.2140
|
Classification Product Code |
|
Date Received | 09/24/1993 |
Decision Date | 04/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|