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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, Calcium
510(k) Number K960120
Device Name STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
Applicant
Nova Biomedical Corp.
200 Prospect St.
Walham,  MA  02454
Applicant Contact PAUL W MACDONALD
Correspondent
Nova Biomedical Corp.
200 Prospect St.
Walham,  MA  02454
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1145
Classification Product Code
JFP  
Subsequent Product Codes
CDS   CFA   CHL   JJS  
Date Received01/11/1996
Decision Date 03/11/1996
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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