510(k) K110182
K110182 is an FDA 510(k) premarket notification submitted by Guangzhou Wondfo Biotech Co., Ltd. for the device "CANNABINOIDS URINE TEST". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Guangzhou Wondfo Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2011
- Date Received
- January 21, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cannabinoids
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type