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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K061282
Device Name ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact JENNIFER RUETHER
Correspondent
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact JENNIFER RUETHER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received05/08/2006
Decision Date 06/02/2006
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
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