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510(k) K103041

VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR by Greiner Bio-One North America, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2010
Date Received
October 14, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Greiner Bio-One North America, Inc.

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  • K122687 — BLOOD CULTURE HOLDER (January 10, 2013)
  • K121908 — SAFETY INFUSION SET (July 25, 2012)
  • K113505 — VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER (February 17, 2012)
  • K102774 — VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER (October 15, 2010)
  • K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR (December 16, 2008)
  • K072320 — GREINER VACUETTE QUICKSHIELD COMPLETE (September 14, 2007)
  • K063357 — MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (July 10, 2007)
  • K061483 — VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES (August 14, 2006)

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