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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 K905264
Device Name STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
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 Number862.1665
Classification Product Code
JGS  
Date Received11/21/1990
Decision Date 03/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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