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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, potassium
510(k) Number K915177
Device Name NOVA 5 NA/K/C1 ALALYZER
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 Number862.1600
Classification Product Code
CEM  
Date Received11/15/1991
Decision Date 01/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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