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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 K963627
Device Name (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Applicant Contact RITA SMITH
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Correspondent Contact RITA SMITH
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JIL   JIX  
Date Received09/11/1996
Decision Date 10/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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