AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K080872
Device Name AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
Applicant
AMEDICA BIOTECH, INC.
28301 industrial blvd suite k
hayward, 
CA 
94545

Applicant Contact jeff chen
Correspondent
AMEDICA BIOTECH, INC.
28301 industrial blvd suite k
hayward, 
CA 
94545

Correspodent Contact jeff chen
Regulation Number 862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIS   DJG   DJR   DKZ   JXM  
JXN   JXO   LCM   LFG  
Date Received 03/31/2008
Decision Date 08/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No