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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K913259
Device Name NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
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 Number864.5220
Classification Product Code
GKZ  
Date Received07/23/1991
Decision Date 10/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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