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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 K981427
Device Name STAT PROFILE M ANALYZER
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   CFA   CGA   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
Recalls CDRH Recalls
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