PRECISET DAT AMPHETAMINE


Device Classification Name

lead, delta amino levulinic acid

510(k) Number K030826
Device Name PRECISET DAT AMPHETAMINE
Applicant
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach, 
CA 
90278 -1205

Applicant Contact gebhard neyer
Correspondent
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach, 
CA 
90278 -1205

Correspodent Contact gebhard neyer
Regulation Number 862.3550
Classification Product Code
DIJ  
Date Received 03/14/2003
Decision Date 04/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No