COBAS INTEGRA ONLINE DAT II METHADONE II


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K021512
Device Name COBAS INTEGRA ONLINE DAT II METHADONE II
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact kerwin kaufman
Regulation Number 862.3620
Classification Product Code
DJR  
Date Received 05/09/2002
Decision Date 07/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No