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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, folic, radioimmunoassay
510(k) Number K082340
Device Name ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact KATHIE J GOODWIN
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact KATHIE J GOODWIN
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIT   JJX   JJY  
Date Received08/15/2008
Decision Date 06/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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