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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 Selective (Non-Specified)
510(k) Number K863438
Device Name NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
Applicant
Nova Biomedical Corp.
200 Prospect St.
Walham,  MA  02454
Applicant Contact PAUL W MACDONALD
Correspondent
Nova Biomedical Corp.
200 Prospect St.
Walham,  MA  02454
Correspondent Contact PAUL W MACDONALD
Regulation Number862.2050
Classification Product Code
JJP  
Date Received09/05/1986
Decision Date 09/29/1986
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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