ONLINE DAT II CANNABINOIDS II


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K030213
Device Name ONLINE DAT II CANNABINOIDS II
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact kerwin kaufman
Regulation Number 862.3870
Classification Product Code
LDJ  
Date Received 01/21/2003
Decision Date 04/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No