510(k) K994409
K994409 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST". The FDA issued a decision of Substantially Equivalent on July 10, 2000. The device falls under product code DPK (Liquid Chromatography, Morphine), a Class II device regulated under 21 CFR 862.3640. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2000
- Date Received
- December 28, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Liquid Chromatography, Morphine
- Device Class
- Class II
- Regulation Number
- 862.3640
- Review Panel
- TX
- Submission Type