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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 K060755
Device Name ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Applicant Contact RANDY J JOHNSON
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Correspondent Contact RANDY J JOHNSON
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
JIT   JJX  
Date Received03/21/2006
Decision Date 04/10/2006
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
Predetermined Change
Control Plan Authorized		 No
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