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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 K844188
Device Name CORNING CALCIUM PH ANALYZER 634
Applicant
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number862.1145
Classification Product Code
JFP  
Date Received10/26/1984
Decision Date 02/04/1985
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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