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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K850587
Device Name SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
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 Number866.5130
Classification Product Code
DEM  
Date Received02/13/1985
Decision Date 03/14/1985
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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