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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K063864
Device Name QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
Applicant
Medical Electronic Systems , Ltd.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Applicant Contact Erika B Ammirati
Correspondent
Medical Electronic Systems , Ltd.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika B Ammirati
Regulation Number864.5220
Classification Product Code
POV  
Date Received12/29/2006
Decision Date 03/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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