510(k) K973153
K973153 is an FDA 510(k) premarket notification submitted by United Biotech, Inc. for the device "UBI MAGIWEL AMPHETAMINE METABOLITES". The FDA issued a decision of Substantially Equivalent on October 28, 1997. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. United Biotech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1997
- Date Received
- August 22, 1997
- 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