FDA 510(k), K061556, AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
FDA 510(k), K061556, AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
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510(K) Number: K061556
Device Name: AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
Manufacturer:
Device Classification Name: Enzyme Immunoassay, Cannabinoids
Regulation Number: 862.3870
Classification Product Code: LDJ
Date Received: 06/05/2006
Decision Date: 07/21/2006
Regulation Medical Specialty: Toxicology
Device Name: AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
Manufacturer:
Device Classification Name: Enzyme Immunoassay, Cannabinoids
Regulation Number: 862.3870
Classification Product Code: LDJ
Date Received: 06/05/2006
Decision Date: 07/21/2006
Regulation Medical Specialty: Toxicology