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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact Jeff Chen
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIS   DJG   DJR   DKZ   JXM  
JXN   JXO   LCM   LFG  
Date Received03/31/2008
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
Predetermined Change
Control Plan Authorized		 No
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