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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-2-Macroglobulin, Antigen, Antiserum, Control
510(k) Number K850603
Device Name SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
Applicant
APPLICATIONS LAB
10 NONESUCH RD.
SCARBOROUGH,  ME  04074
Applicant Contact GLENN R IRISH
Correspondent
APPLICATIONS LAB
10 NONESUCH RD.
SCARBOROUGH,  ME  04074
Correspondent Contact GLENN R IRISH
Regulation Number866.5620
Classification Product Code
DEB  
Date Received02/15/1985
Decision Date 03/05/1985
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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