Device Classification Name |
diazo (colorimetric), nitrite (urinary, non-quant)
|
510(k) Number |
K170118 |
Device Name |
Scanostics UTI Check Application Test System |
Applicant |
Teco Diagnostics |
1268 N Lakeview Ave |
Anaheim,
CA
92807
|
|
Applicant Contact |
Ling Koh |
Correspondent |
Teco Diagnostics |
1268 N Lakeview Ave |
Anaheim,
CA
92807
|
|
Correspondent Contact |
Ling Koh |
Regulation Number | 862.1510
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/13/2017 |
Decision Date | 09/21/2017 |
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
|
|
|