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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K993952
Device Name IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact EDWARD M LEVINE
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact EDWARD M LEVINE
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received11/22/1999
Decision Date 12/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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