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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K981426
Device Name STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
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 Number864.5600
Classification Product Code
GKF  
Subsequent Product Codes
CDS   CEM   CGA   CGZ   CHL  
GKR   JFP   JGS   JIX   JJS   KHP  
Date Received04/16/1998
Decision Date 05/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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