Device Classification Name |
method, enzymatic, glucose (urinary, non-quantitative)
|
510(k) Number |
K183432 |
Device Name |
cobas u 601 urinalysis test system |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Angela Clements |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Angela Clements |
Regulation Number | 862.1340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/11/2018 |
Decision Date | 05/07/2019 |
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
|
Recalls |
CDRH Recalls
|
|
|