AMEDICA DRUG SCREEN AMPHETAMINE TEST


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K023104
Device Name AMEDICA DRUG SCREEN AMPHETAMINE TEST
Original Applicant
AMEDICA BIOTECH, INC.
28301 industrial blvd suite k
hayward, 
CA 
94545

Original Contact jeff chen
Regulation Number 862.3100
Classification Product Code
DKZ  
Date Received 09/18/2002
Decision Date 12/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No