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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Immunoglobulins (G, A, M)
510(k) Number K890561
Device Name SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
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 Number866.5510
Classification Product Code
CFQ  
Date Received01/24/1989
Decision Date 02/23/1989
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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