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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C9, Antigen, Antiserum, Control
510(k) Number K974111
Device Name QUIDEL CH50 EQ EIA
Applicant
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact Robin Weiner
Correspondent
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number866.5240
Classification Product Code
DAE  
Date Received10/31/1997
Decision Date 07/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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