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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 K896526
Device Name LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
Applicant
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KRISTA U SMALLEY
Correspondent
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KRISTA U SMALLEY
Regulation Number862.1665
Classification Product Code
JGS  
Date Received11/13/1989
Decision Date 01/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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