URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
FDA 510(k) clearance K131600 · decided 2014-05-29
Clearance details
- K-number
- K131600
- Device name
- URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
- Applicant
- Teco Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2013-06-03
- Decision date
- 2014-05-29
- Days to decision
- 360 days
- Clearance type
- Traditional
- Product code
- JIL
- Device class
- 2
- Regulation number
- 862.1340
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.