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510(k) K233979

VACUETTE® QUICKSHIELD Complete (Plus) by Greiner Bio-One North America, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2024
Date Received
December 18, 2023
Clearance Type
Traditional
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.

  • 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)
  • 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)

Other clearances for product code JKA

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  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K244047 — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (May 23, 2025)
  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K232781 — Safety Sliding Blood Collection Set (March 7, 2024)