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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 (Photometric, Discrete), For Clinical Use
510(k) Number K923579
Device Name MINIVIDAS INSTRUMENT
Applicant
BIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD,  MO  63042 -2395
Applicant Contact CHRYL WINTERS-HEARD
Correspondent
BIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD,  MO  63042 -2395
Correspondent Contact CHRYL WINTERS-HEARD
Regulation Number862.2160
Classification Product Code
JJE  
Date Received07/20/1992
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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