CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500


Device Classification Name

drug mixture control materials

510(k) Number K080183
Device Name CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd. bx 50416
indianapolis, 
IN 
46250 -0416

Applicant Contact dimitris demirtzoglou
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd. bx 50416
indianapolis, 
IN 
46250 -0416

Correspodent Contact dimitris demirtzoglou
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 01/25/2008
Decision Date 03/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No