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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, Micro, For Clinical Use
510(k) Number K973628
Device Name VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
Applicant
VITAL SCIENTIFIC N.V.
ONE GATEWAY CENTER SUITE 415
NEWTON,  MA  02158
Applicant Contact ISRAEL M STEIN
Correspondent
VITAL SCIENTIFIC N.V.
ONE GATEWAY CENTER SUITE 415
NEWTON,  MA  02158
Correspondent Contact ISRAEL M STEIN
Regulation Number862.2170
Classification Product Code
JJF  
Subsequent Product Codes
CDN   CEM   CGA   DJC   DKZ  
JGS   JRE   JXO   KLT   LAR  
Date Received09/24/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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