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510(k) K122687

BLOOD CULTURE HOLDER by Greiner Bio-One North America, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2013
Date Received
September 4, 2012
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.

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  • 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)

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