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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 K891154
Device Name SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
Applicant
Atlantic Antibodies
10 Nonesuch Rd.
P.O. Box 60
Scarborough,  ME  04074
Applicant Contact GLENN R IRISH
Correspondent
Atlantic Antibodies
10 Nonesuch Rd.
P.O. Box 60
Scarborough,  ME  04074
Correspondent Contact GLENN R IRISH
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received03/06/1989
Decision Date 03/16/1989
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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