URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS— 510(k) K082811
Substantially EquivalentUrit Medical Electronic Co., Ltd.
FDA 510(k) clearance K082811 for URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS, Substantially Equivalent on 2009-09-11. Applicant: Urit Medical Electronic Co., Ltd..
Clearance details
- Applicant
- Urit Medical Electronic Co., Ltd.
- Product code
- Code JIO
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.