Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K050026 |
Device Name |
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC |
Applicant |
Roche Diagnostics |
9115 HAGUE ROAD |
INDIANAPOLIS,
IN
46250 -0416
|
|
Applicant Contact |
THERESA M AMBROSE |
Correspondent |
Roche Diagnostics |
9115 HAGUE ROAD |
INDIANAPOLIS,
IN
46250 -0416
|
|
Correspondent Contact |
THERESA M AMBROSE |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/06/2005 |
Decision Date | 01/31/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|