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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 K904776
Device Name CEDIA (R) VITAMIN B12/FOLATE ASSAY
Applicant
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact Patricia M Klimley
Correspondent
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact Patricia M Klimley
Regulation Number862.1810
Classification Product Code
CDD  
Date Received10/22/1990
Decision Date 11/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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