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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
Applicant
Greiner Bio-One North America, Inc.
P.O.Box 103
Baldwin,  MD  21013
Applicant Contact Judi Smith
Correspondent
Greiner Bio-One North America, Inc.
P.O.Box 103
Baldwin,  MD  21013
Correspondent 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 Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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