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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 K841575
Device Name SENTECH'S ULAB 1000 CLINICAL CHEM.
Applicant
SENTECH MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SENTECH MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1600
Classification Product Code
CEM  
Date Received04/17/1984
Decision Date 07/06/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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