AMEDICA DRUG SCREEN OPIATES TEST


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K023047
Device Name AMEDICA DRUG SCREEN OPIATES TEST
Original Applicant
AMEDICA BIOTECH, INC.
28301 industrial blvd suite k
hayward, 
CA 
94545

Original Contact jeff chen
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 09/12/2002
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