AMEDICA DRUG SCREEN COCAINE TEST


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K022954
Device Name AMEDICA DRUG SCREEN COCAINE TEST
Original Applicant
AMEDICA BIOTECH, INC.
28301 industrial blvd suite k
hayward, 
CA 
94545

Original Contact jeff chen
Regulation Number 862.3250
Classification Product Code
DIO  
Date Received 09/05/2002
Decision Date 11/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No