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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxyhemoglobin
510(k) Number K200204
Device Name Stat Profile Prime Plus Analyzer System
Applicant
Nova Biomedical Corporation
200 Prospect Street
Waltham,  MA  02454
Applicant Contact Rachel Gilbert
Correspondent
Nova Biomedical Corporation
200 Prospect Street
Waltham,  MA  02454
Correspondent Contact Rachel Gilbert
Regulation Number864.7500
Classification Product Code
GGZ  
Subsequent Product Codes
GHS   GKK   GKR   JPI  
Date Received01/28/2020
Decision Date 04/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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
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