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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 K180186
Device Name Stat Profile Prime Plus Analyzer System
Applicant
Nova Biomedical Corporation
200 Prospect St.
Waltham,  MA  02454
Applicant Contact Adam Heroux
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Waltham,  MA  02454
Correspondent Contact Cesidio Tempesta
Regulation Number864.7500
Classification Product Code
GGZ  
Subsequent Product Codes
GHS   GKK   GKR   JPI  
Date Received01/23/2018
Decision Date 08/23/2018
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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