DRI METHADONE METABOLITE ENZYME IMMUNOASSAY


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K023617
Device Name DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
Original Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont, 
CA 
94538

Original Contact lakshmi anne
Regulation Number 862.3620
Classification Product Code
DJR  
Subsequent Product Codes
DLJ   LAS  
Date Received 10/29/2002
Decision Date 08/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No