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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 K991727
Device Name STAT PROFILE M7 ANALYZER
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 Number862.1225
Classification Product Code
CGL  
Subsequent Product Codes
CDS   CEM   CGA   CGZ   CHL  
GLY   JFP   JGS   JKS   JPI   KHP  
Date Received05/20/1999
Decision Date 07/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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