510(k) K940912
K940912 is an FDA 510(k) premarket notification submitted by U.S. Drug Testing, Inc. for the device "USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500". The FDA issued a decision of Substantially Equivalent on June 2, 1994. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. U.S. Drug Testing, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1994
- Date Received
- February 25, 1994
- 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