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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, Sodium
510(k) Number K881255
Device Name NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
Applicant
Nova Biomedical Corp.
200 Prospect St.
Waltham,  MA  02454 -9141
Applicant Contact PAUL W MACDONALD
Correspondent
Nova Biomedical Corp.
200 Prospect St.
Waltham,  MA  02454 -9141
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1665
Classification Product Code
JGS  
Date Received03/23/1988
Decision Date 05/16/1988
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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