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510(k) K081929

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2008
Date Received
July 7, 2008
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.

  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)
  • K122687 — BLOOD CULTURE HOLDER (January 10, 2013)
  • K121908 — SAFETY INFUSION SET (July 25, 2012)
  • K113505 — VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER (February 17, 2012)
  • K103041 — VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR (November 9, 2010)
  • K102774 — VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER (October 15, 2010)
  • 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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