DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K081378
Device Name DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
Applicant
Thermo Fisher Scientific
46360 fremont blvd.
fremont, 
CA 
94538

Applicant Contact jack rogers
Correspondent
Thermo Fisher Scientific
46360 fremont blvd.
fremont, 
CA 
94538

Correspodent Contact jack rogers
Regulation Number 862.3620
Classification Product Code
DJR  
Subsequent Product Codes
DIF   DKB  
Date Received 05/16/2008
Decision Date 01/14/2009
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