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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K895717
Device Name SODIUM AND POTASSIUM STANDARD
Applicant
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact ANNETTE T WELLS
Correspondent
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact ANNETTE T WELLS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received09/25/1989
Decision Date 01/11/1990
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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