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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 K854945
Device Name MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Applicant Contact William J Pignato
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Correspondent Contact William J Pignato
Regulation Number862.1810
Classification Product Code
CDD  
Date Received12/10/1985
Decision Date 02/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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