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510(k) K853140

MDI QUIK TEST NARCOTICS DRUG SCREEN by Medical Diagnostics, Ca. — Product Code DNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1986
Date Received
July 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

Other clearances by Medical Diagnostics, Ca.

  • K843900 — FOCUSCOPE UNIVERSAL SYSTEM (December 6, 1984)
  • K843343 — MEDICA IIF-ANTI-THYROID ANTIBODY TEST (October 22, 1984)
  • K831100 — MEDICA IIF-MULTIPLE ANTIBODY TEST KIT (May 4, 1983)

Other clearances for product code DNK

  • K151557 — EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - (July 16, 2015)
  • K150602 — CR3 Keyless Split Sample Cup Morphine - Methamphetamine (April 7, 2015)
  • K970579 — ONE STEP MORPHINE CARD TEST (July 3, 1997)