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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, Calcium
510(k) Number K860639
Device Name IONIZED CALCIUM AND BLOOD PH TESTCARDS
Applicant
Ilex Corp.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact W. A MORTON
Correspondent
Ilex Corp.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact W. A MORTON
Regulation Number862.1145
Classification Product Code
JFP  
Date Received02/20/1986
Decision Date 04/21/1986
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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