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Amedica Biotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K100108AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCAApril 14, 2010
K082898AMEDICA DRUG SCREEN TEST CUPDecember 19, 2008
K080872AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZAugust 19, 2008
K063379AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220December 11, 2006
K061556AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020July 21, 2006
K040464AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TESTMay 17, 2004
K031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TESTOctober 17, 2003
K023101AMEDICA DRUG SCREEN METHAPHETAMINE TESTDecember 16, 2002
K023104AMEDICA DRUG SCREEN AMPHETAMINE TESTDecember 16, 2002
K023109AMEDICA DRUG SCREEN PHENCYCLIDINE TESTDecember 16, 2002
K022954AMEDICA DRUG SCREEN COCAINE TESTNovember 6, 2002
K023047AMEDICA DRUG SCREEN OPIATES TESTNovember 6, 2002
K022955AMEDICA DRUG SCREEN THC TESTNovember 6, 2002