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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
510(k) Number K945584
Device Name NOVA 16 ANALYZER
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 Number862.2150
Classification Product Code
JJC  
Subsequent Product Codes
CDS   CEM   CGA   CGL   CGZ  
JFL   JIX   JPI   JPK  
Date Received11/14/1994
Decision Date 02/08/1995
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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