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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K945080
Device Name QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
Applicant
Quidel Corp.
10165 Mckellar Court
San Diego,  CA  92121
Applicant Contact LINDA G THOSS
Correspondent
Quidel Corp.
10165 Mckellar Court
San Diego,  CA  92121
Correspondent Contact LINDA G THOSS
Regulation Number866.3740
Classification Product Code
GTY  
Date Received10/17/1994
Decision Date 02/10/1995
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
Recalls CDRH Recalls
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