COBAS INTEGRA ONLINE DAT II COCAINE II


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K023296
Device Name COBAS INTEGRA ONLINE DAT II COCAINE II
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact kerwin kaufman
Regulation Number 862.3250
Classification Product Code
DIO  
Date Received 10/02/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No