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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K951057
Device Name MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
Applicant
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact PATRICIA V WILLIS
Correspondent
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact PATRICIA V WILLIS
Regulation Number866.5270
Classification Product Code
DCK  
Date Received03/07/1995
Decision Date 04/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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