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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 K043318
Device Name MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact KAY A TAYLOR
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact KAY A TAYLOR
Regulation Number862.1295
Classification Product Code
CGN  
Date Received12/02/2004
Decision Date 12/23/2004
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
Recalls CDRH Recalls
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