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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K861167
Device Name IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
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 Number866.5510
Classification Product Code
CZP  
Date Received03/28/1986
Decision Date 04/25/1986
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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