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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 K972748
Device Name CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
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 Number862.1155
Classification Product Code
JHI  
Date Received07/23/1997
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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