|
Document Number | K100024 |
Test Name | Uqora, Inc. Clarity Urinary tract infection (UTI) test |
Manufacturer Name | TECO DIAGNOSTICS |
Consumer Information Phone Number | +1(408)713-3880 |
Test Type | Leukocyte esterase, urinary |
Effective Date | 03/27/2020 |
| |
Device Classification Name |
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
|
510(k) Number |
K100024 |
Device Name |
TECO DIAGNOSTICS UTI DETECTION STRIPS |
Applicant |
TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. |
ANAHEIM,
CA
92807
|
|
Applicant Contact |
KC CHEN |
Correspondent |
TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. |
ANAHEIM,
CA
92807
|
|
Correspondent Contact |
KC CHEN |
Regulation Number | 862.1510
|
Classification Product Code |
|
Subsequent Product Code |
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Date Received | 01/05/2010 |
Decision Date | 02/17/2011 |
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
|
|
|
|