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510(k) K031497

AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST by Amedica Biotech, Inc. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2003
Date Received
May 13, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Amedica Biotech, Inc.

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  • K082898 — AMEDICA DRUG SCREEN TEST CUP (December 19, 2008)
  • K080872 — AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ (August 19, 2008)
  • K063379 — AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C121 (December 11, 2006)
  • K061556 — AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1 (July 21, 2006)
  • K040464 — AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST (May 17, 2004)
  • K023109 — AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (December 16, 2002)
  • K023104 — AMEDICA DRUG SCREEN AMPHETAMINE TEST (December 16, 2002)
  • K023101 — AMEDICA DRUG SCREEN METHAPHETAMINE TEST (December 16, 2002)
  • K022955 — AMEDICA DRUG SCREEN THC TEST (November 6, 2002)

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