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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Immunological, Antigen, Tumor
510(k) Number K013984
Device Name IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number866.6010
Classification Product Code
MOI  
Date Received12/03/2001
Decision Date 03/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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