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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Beta-2-Microglobulin Immunological
510(k) Number K946048
Device Name LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
Applicant
Clinical Controls, Inc.
750 Farroll Rd.
Suite B
Grover Beach,  CA  93433
Applicant Contact JAMES F GODFREY
Correspondent
Clinical Controls, Inc.
750 Farroll Rd.
Suite B
Grover Beach,  CA  93433
Correspondent Contact JAMES F GODFREY
Regulation Number866.5630
Classification Product Code
JZG  
Date Received12/12/1994
Decision Date 02/10/1995
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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