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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 K954322
Device Name TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
Applicant
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact KEVIN KENNAN
Correspondent
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact KEVIN KENNAN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received09/15/1995
Decision Date 10/11/1995
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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