510(k) K963654
K963654 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUIKSTRIP ONESTEP MARIJUANA (THC) TEST". The FDA issued a decision of Substantially Equivalent on February 28, 1997. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1997
- Date Received
- September 12, 1996
- 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