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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 K896316
Device Name EOS IONIZED CALCIUM TEST CARD
Applicant
Eos Technology Corp.
10161 Harwin, Suite 150
Houston,  TX  77036
Applicant Contact JOYCE HEINRICH
Correspondent
Eos Technology Corp.
10161 Harwin, Suite 150
Houston,  TX  77036
Correspondent Contact JOYCE HEINRICH
Regulation Number862.1145
Classification Product Code
JFP  
Date Received11/01/1989
Decision Date 02/13/1990
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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