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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 K934484
Device Name QUICKVUE IN-LINE ONE-STEP STREP A TEST
Applicant
Quidel Corp.
10165 Mckellar Court
San Diego,  CA  92121
Applicant Contact Robin Weiner
Correspondent
Quidel Corp.
10165 Mckellar Court
San Diego,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received09/14/1993
Decision Date 07/18/1994
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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