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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
Recalls CDRH Recalls
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