510(k) K994409

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST by Alfa Scientific Designs, Inc. — Product Code DPK

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