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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroglobulin
510(k) Number K002905
Device Name ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
Applicant
BECKMAN COULTER, INC.
7330 CARROLL RD.
P.O. BOX 269006
SAN DIEGO,  CA  92196
Applicant Contact MARA CALER
Correspondent
BECKMAN COULTER, INC.
7330 CARROLL RD.
P.O. BOX 269006
SAN DIEGO,  CA  92196
Correspondent Contact MARA CALER
Regulation Number866.6010
Classification Product Code
MSW  
Date Received09/18/2000
Decision Date 10/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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