510(k) K932318
K932318 is an FDA 510(k) premarket notification submitted by U.S. Drug Testing, Inc. for the device "USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200". The FDA issued a decision of Substantially Equivalent on June 15, 1993. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. U.S. Drug Testing, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1993
- Date Received
- May 11, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type