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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K871252
Device Name RSR CARD TEST
Applicant
Advanced Polymer Systems, Inc.
3696c Haven Ave.
Redwood City,  CA  94063
Applicant Contact MARTIN KATZ
Correspondent
Advanced Polymer Systems, Inc.
3696c Haven Ave.
Redwood City,  CA  94063
Correspondent Contact MARTIN KATZ
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received03/30/1987
Decision Date 08/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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