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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 BK070029
Tradename S-Monovette ACD-A
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Original Applicant
Sarstedt, Inc.
1025 saint james church rd.
newton,  NC  20865
Regulation Number862.1675
Classification Product Code
JKA  
Date Received05/31/2007
Decision Date 09/21/2007
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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