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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K831108
Device Name HOME PREGNANCY TEST KIT
Applicant
Quidel Corp.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent
Quidel Corp.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/05/1983
Decision Date 05/18/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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