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510(k) K082898

AMEDICA DRUG SCREEN TEST CUP by Amedica Biotech, Inc. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2008
Date Received
September 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Amedica Biotech, Inc.

  • K100108 — AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA (April 14, 2010)
  • 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)
  • K031497 — AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (October 17, 2003)
  • K023101 — AMEDICA DRUG SCREEN METHAPHETAMINE TEST (December 16, 2002)
  • K023104 — AMEDICA DRUG SCREEN AMPHETAMINE TEST (December 16, 2002)
  • K023109 — AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (December 16, 2002)
  • K022954 — AMEDICA DRUG SCREEN COCAINE TEST (November 6, 2002)

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