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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Applicant Contact GEBHARD NEYER
Correspondent
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact GEBHARD NEYER
Regulation Number862.3550
Classification Product Code
DIJ  
Date Received03/14/2003
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
Predetermined Change
Control Plan Authorized		 No
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