AMEDICA DRUG SCREEN OPIATES TEST

Enzyme Immunoassay, Opiates

AMEDICA BIOTECH, INC.

The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Screen Opiates Test.

Pre-market Notification Details

Device IDK023047
510k NumberK023047
Device Name:AMEDICA DRUG SCREEN OPIATES TEST
ClassificationEnzyme Immunoassay, Opiates
Applicant AMEDICA BIOTECH, INC. 28301 INDUSTRIAL BLVD SUITE K Hayward,  CA  94545
ContactJeff Chen
CorrespondentJeff Chen
AMEDICA BIOTECH, INC. 28301 INDUSTRIAL BLVD SUITE K Hayward,  CA  94545
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-12
Decision Date2002-11-06
Summary:summary

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