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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 K200403
Device Name Stat Profile Prime Plus Analyzer System
Applicant
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Applicant Contact Rachel Gilbert
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Correspondent Contact Rachel Gilbert
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CFA   CGZ   JFP  
Date Received02/19/2020
Decision Date 04/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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