URS-2GP (GLUCOSE PROTEIN) URINE STRIPS— 510(k) K131600
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K131600 for URS-2GP (GLUCOSE PROTEIN) URINE STRIPS, Substantially Equivalent on 2014-05-29. Applicant: Teco Diagnostics. Device class: 2.
Clearance details
- Applicant
- Teco Diagnostics
- Product code
- Code JIL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1340
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.