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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 K951134
Device Name CEDIA VITAMIN B12 (NO BOIL) ASSAY
Applicant
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Applicant Contact MARY KONING
Correspondent
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Correspondent Contact MARY KONING
Regulation Number862.1810
Classification Product Code
CDD  
Date Received03/13/1995
Decision Date 07/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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