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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K892526
Device Name SPQ TM TEST SYSTEM II FOR CRP
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 Number866.5270
Classification Product Code
DCK  
Date Received04/11/1989
Decision Date 05/09/1989
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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