510(k) K142800
K142800 is an FDA 510(k) premarket notification submitted by Co-Innovation Biotech Co., Ltd. for the device "Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard". The FDA issued a decision of Substantially Equivalent on December 11, 2014. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Co-Innovation Biotech Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2014
- Date Received
- September 29, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type