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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 K833696
Device Name ACID BASE LABORATORY ABL4
Applicant
RADIOMETER AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RADIOMETER AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1600
Classification Product Code
CEM  
Date Received10/18/1983
Decision Date 01/18/1984
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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