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510(k) K972577

QUICK SCREEN ONE STEP AMPHETAMINE TEST by Phamatech — Product Code DIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
July 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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Other clearances for product code DIT

  • K910525 — MICROLINE SCREEN FOR METHAMPHETAMINE (April 5, 1991)
  • K901276 — HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL (April 26, 1990)
  • K790805 — DRUG ABUSE DIPSTICKS (June 6, 1979)