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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 BK040066
Tradename Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Original Applicant
Greiner Vacuette North America, Inc.
4238 capital dr
monroe,  NC  28110
Regulation Number862.1675
Classification Product Code
JKA  
Date Received08/18/2004
Decision Date 09/10/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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