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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein X, Antigen, Antiserum, Control
510(k) Number K893885
Device Name BACTON TM, BASIC TM, APO A-I 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 Number866.5590
Classification Product Code
DEL  
Date Received05/30/1989
Decision Date 06/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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