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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K060929
Device Name IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
Applicant
DIAGNOSTIC PRODUCTS CORPORATION
5210 PACIFIC CONCOURSE DR.
LOS ANGELES,  CA  90045 -6900
Applicant Contact DEBORAH L MORRIS
Correspondent
DIAGNOSTIC PRODUCTS CORPORATION
5210 PACIFIC CONCOURSE DR.
LOS ANGELES,  CA  90045 -6900
Correspondent Contact DEBORAH L MORRIS
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Code
CGN  
Date Received04/05/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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