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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K893884
Device Name BACTON TM, BASIC TM, APO B REAGENT
Applicant
Catachem, Inc.
955 Connecticut Ave.
Bridgeport,  CT  06606
Applicant Contact GEORGE LIGGINS
Correspondent
Catachem, Inc.
955 Connecticut Ave.
Bridgeport,  CT  06606
Correspondent Contact GEORGE LIGGINS
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received05/30/1989
Decision Date 06/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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