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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 K010050
Device Name ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
Applicant
Bayer Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact THOMAS F FLYNN
Correspondent
Bayer Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact THOMAS F FLYNN
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Code
JJX  
Date Received01/05/2001
Decision Date 02/05/2001
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
Recalls CDRH Recalls
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