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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K820629
Device Name CORNING 902 SODIUM POTASSIUM ANALYZER
Applicant
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1410
Classification Product Code
CFM  
Date Received03/08/1982
Decision Date 03/25/1982
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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