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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K993546
Device Name TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
Applicant
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact SCOT KINGHORN
Correspondent
Medical Analysis Systems, Inc.
Lincoln Technology Park
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact SCOT KINGHORN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/19/1999
Decision Date 11/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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