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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antibody igm,if, cytomegalovirus virus
510(k) Number K100433
Device Name IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO,  CA  95691
Applicant Contact ROBERT C EUSEBIO
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO,  CA  95691
Correspondent Contact ROBERT C EUSEBIO
Regulation Number866.3175
Classification Product Code
LKQ  
Subsequent Product Codes
JIT   JJX  
Date Received02/16/2010
Decision Date 05/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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