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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K032826
Device Name MAS PAR TDM
Applicant
Medical Analysis Systems, Inc.
5300 Adolfo Rd.
Camarillo,  CA  93012
Applicant Contact PENNY M LAYMAN
Correspondent
Medical Analysis Systems, Inc.
5300 Adolfo Rd.
Camarillo,  CA  93012
Correspondent Contact PENNY M LAYMAN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received09/10/2003
Decision Date 10/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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