510(k) K993984
K993984 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL". The FDA issued a decision of Substantially Equivalent on January 18, 2000. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Syva Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2000
- Date Received
- November 24, 1999
- 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