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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K102175
Device Name RAPIDVUE HCG TEST
Applicant
Quidel Corporation
10165 Mckellar Court
San Diego,  CA  92121
Applicant Contact Michelle Bodien
Correspondent
Quidel Corporation
10165 Mckellar Court
San Diego,  CA  92121
Correspondent Contact Michelle Bodien
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/02/2010
Decision Date 08/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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