510(k) K082811
K082811 is an FDA 510(k) premarket notification submitted by Urit Medical Electronic Co., Ltd. for the device "URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS". The FDA issued a decision of Substantially Equivalent on September 11, 2009. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. Urit Medical Electronic Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2009
- Date Received
- September 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood, Occult, Colorimetric, In Urine
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type