Device Classification Name |
method, enzymatic, glucose (urinary, non-quantitative)
|
510(k) Number |
K180356 |
Device Name |
inui In-Home Urine Analysis Test System |
Applicant |
Scanadu, Inc. |
1196 Borregas Ave., Ste 200 |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
Daya Ranamukhaarachchi |
Correspondent |
Scanadu, Inc. |
1196 Borregas Ave., Ste 200 |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Daya Ranamukhaarachchi |
Regulation Number | 862.1340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/08/2018 |
Decision Date | 05/25/2018 |
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
|
|
|