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510(k) K994404

INSTANT-VIEW MORPHINE URINE CASSETTE TEST by Alfa Scientific Designs, Inc. — Product Code DPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 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

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Other clearances for product code DPK

  • K994409 — INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST (July 10, 2000)