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FDA 510(k), K063379, AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
FDA 510(k), K063379, AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
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510(K) Number: K063379
Device Name: AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
Manufacturer: AMEDICA BIOTECH, INC.
Device Classification Name: enzyme immunoassay, amphetamine
Regulation Number: 862.3100
Classification Product Code: DKZ
Date Received: 11/08/2006
Decision Date: 12/11/2006
Regulation Medical Specialty: Toxicology
Device Name: AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
Manufacturer: AMEDICA BIOTECH, INC.
Device Classification Name: enzyme immunoassay, amphetamine
Regulation Number: 862.3100
Classification Product Code: DKZ
Date Received: 11/08/2006
Decision Date: 12/11/2006
Regulation Medical Specialty: Toxicology
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