510(k) K153646
K153646 is an FDA 510(k) premarket notification submitted by Safecare Biotech (Hangzhou) Co., Ltd. for the device "SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana". The FDA issued a decision of Substantially Equivalent on March 18, 2016. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Safecare Biotech (Hangzhou) Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2016
- Date Received
- December 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type