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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 Based, Enzymatic, Creatinine
510(k) Number K070068
Device Name NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
Applicant
Nova Biomedical Corp.
200 Prospect St.
Waltham,  MA  02454 -9141
Applicant Contact PAUL W MACDONALD,PHD
Correspondent
Nova Biomedical Corp.
200 Prospect St.
Waltham,  MA  02454 -9141
Correspondent Contact PAUL W MACDONALD,PHD
Regulation Number862.1225
Classification Product Code
CGL  
Subsequent Product Code
JJX  
Date Received01/08/2007
Decision Date 05/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
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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