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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 K971058
Device Name DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
Applicant
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012 -8058
Applicant Contact SCOT KINGHORN
Correspondent
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012 -8058
Correspondent Contact SCOT KINGHORN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received03/24/1997
Decision Date 04/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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