Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K042549 |
Device Name |
MULTI CHEM CAL B |
Applicant |
WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD |
RICHMOND,
VA
23237
|
|
Applicant Contact |
LORI CREASY |
Correspondent |
WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD |
RICHMOND,
VA
23237
|
|
Correspondent Contact |
LORI CREASY |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 09/20/2004 |
Decision Date | 11/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|