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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 K033041
Device Name ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
Original Applicant
ACON LABORATORIES, INC.
4108 sorrento valley blvd.
san diego,  CA  92121
Original Contact edward tung
Regulation Number862.1155
Classification Product Code
LCX  
Date Received09/29/2003
Decision Date 11/21/2003
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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