510(k) K133710
K133710 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS". The FDA issued a decision of Substantially Equivalent on February 21, 2014. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2014
- Date Received
- December 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrators, Drug Mixture
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type