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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 K983127
Device Name OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
Applicant
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact MARY THORSNESS
Correspondent
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact MARY THORSNESS
Regulation Number862.3280
Classification Product Code
DIF  
Date Received09/08/1998
Decision Date 09/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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