IND URINARY TRACT INFECTION (UTI) TEST STRIPS
FDA 510(k) clearance K103037 · decided 2012-04-17
Clearance details
- K-number
- K103037
- Device name
- IND URINARY TRACT INFECTION (UTI) TEST STRIPS
- Applicant
- Ind Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-14
- Decision date
- 2012-04-17
- Days to decision
- 551 days
- Clearance type
- Traditional
- Product code
- NGJ
- Device class
- 1
- Regulation number
- 862.1510
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Delta, B.C., CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ind Diagnostic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HealthyWiser UriTest" UTI Test Strips REF 900-UTI recall (Z-0045-2024) | Universal Meditech Inc. | 2023-10-23 |