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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K053165
Device Name ISE INDIRECT NA, K, CL FOR GEN.2
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Applicant Contact KERWIN KAUFMAN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250
Correspondent Contact KERWIN KAUFMAN
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ  
Date Received11/14/2005
Decision Date 12/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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