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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K122687
Device Name BLOOD CULTURE HOLDER
Original Applicant
GREINER BIO-ONE NORTH AMERICA, INC.
p.o. box 103
baldwin,  MD  21013
Original Contact judi smith
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/04/2012
Decision Date 01/10/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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