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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 K103221
Device Name ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
Applicant
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianaoplis,  IN  46250 -0416
Applicant Contact KELLY C O'MAINE ADAMS
Correspondent
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50416
Indianaoplis,  IN  46250 -0416
Correspondent Contact KELLY C O'MAINE ADAMS
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJX  
Date Received11/01/2010
Decision Date 12/23/2010
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
Predetermined Change
Control Plan Authorized		 No
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