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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 K853068
Device Name ILEX PROMPT CLINICAL CHEMISTRY ANALYER
Applicant
Ilex Corp.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
Ilex Corp.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number862.1600
Classification Product Code
CEM  
Date Received07/22/1985
Decision Date 10/31/1985
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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