Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K040264 |
Device Name |
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
SHERRI L COENEN |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
SHERRI L COENEN |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 02/04/2004 |
Decision Date | 04/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|