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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K852806
Device Name QUIDEL QUEST STREP GROUP A TEST
Applicant
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact ALBERT B SYNDER
Correspondent
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact ALBERT B SYNDER
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received07/03/1985
Decision Date 07/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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