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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 K936166
Device Name CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
Applicant
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact DONNA L ANDERSON
Correspondent
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact DONNA L ANDERSON
Regulation Number862.3280
Classification Product Code
DIF  
Date Received12/22/1993
Decision Date 07/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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