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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, vancomycin
510(k) Number K063045
Device Name IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
Applicant
DIAGNOSTIC PRODUCTS CORP.
5210 PACIFIC CONCOURCE DR.
los angeles,  CA  90045 -6900
Applicant Contact deborah l morris
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5210 PACIFIC CONCOURCE DR.
los angeles,  CA  90045 -6900
Correspondent Contact deborah l morris
Regulation Number862.3950
Classification Product Code
LEH  
Date Received10/04/2006
Decision Date 12/05/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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