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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Antigen, Antiserum, Control
510(k) Number K884297
Device Name SPQ(TM) TEST SYSTEM FOR PREALBUMIN
Applicant
Atlantic Antibodies
10 Nonesuch Rd.
P.O. Box 60
Scarborough,  ME  04074
Applicant Contact THOMAS SNYDER
Correspondent
Atlantic Antibodies
10 Nonesuch Rd.
P.O. Box 60
Scarborough,  ME  04074
Correspondent Contact THOMAS SNYDER
Regulation Number866.5060
Classification Product Code
JZJ  
Date Received10/12/1988
Decision Date 11/02/1988
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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