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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, Potassium
510(k) Number K842315
Device Name ULTRA LYTE ANALYZER I 100
Applicant
Ultra Quest Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ultra Quest Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1600
Classification Product Code
CEM  
Date Received06/12/1984
Decision Date 08/02/1984
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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