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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 K843453
Device Name ULTRA LYTE SODIUM REAGENT KIT
Applicant
Ultra Quest Diagnostics, Inc.
1404 N. Main St.
Indianapolis,  IN  46224
Applicant Contact BRADY
Correspondent
Ultra Quest Diagnostics, Inc.
1404 N. Main St.
Indianapolis,  IN  46224
Correspondent Contact BRADY
Regulation Number862.1665
Classification Product Code
JGS  
Date Received09/05/1984
Decision Date 11/27/1984
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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