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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Quality Control, Semen Analysis
510(k) Number K041600
Device Name QWIKCHECK-BEADS
Applicant
Medical Electronics Systems , Ltd.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Applicant Contact Erika B Ammirati
Correspondent
Medical Electronics Systems , Ltd.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika B Ammirati
Regulation Number864.8625
Classification Product Code
NRF  
Subsequent Product Code
JJW  
Date Received06/14/2004
Decision Date 07/27/2004
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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