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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 K063357
Device Name MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
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 Received11/07/2006
Decision Date 07/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
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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