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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 K881898
Device Name MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
Applicant
Atlantic Antibodies
10 Nonesuch Rd.
P.O. Box 60
Scarborough,  ME  04074
Applicant Contact GLENN IRISH
Correspondent
Atlantic Antibodies
10 Nonesuch Rd.
P.O. Box 60
Scarborough,  ME  04074
Correspondent Contact GLENN IRISH
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received04/28/1988
Decision Date 06/14/1988
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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