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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K850588
Device Name SPQ TEST SYSTEM FOR COMPLEMENT C3
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 Number866.5240
Classification Product Code
CZW  
Date Received02/13/1985
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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