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510(k) K011699

VACUETTE EVACUATED BLOOD COLLECTION TUBES by Greiner Bio-One Vacuette North America — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2001
Date Received
June 1, 2001
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 Vacuette North America

  • K080235 — SAFETY INFUSION SET (April 24, 2008)
  • K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (April 15, 2005)
  • K033478 — VACUETTE QUICKSHIELD SAFETY TUBE HOLDER (December 29, 2003)
  • K023971 — VACUETTE TRACE ELEMENTS TUBES (January 27, 2003)

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