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510(k) K033478

VACUETTE QUICKSHIELD SAFETY TUBE HOLDER by Greiner Bio-One Vacuette North America — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2003
Date Received
November 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Greiner Bio-One Vacuette North America

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  • K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (April 15, 2005)
  • K023971 — VACUETTE TRACE ELEMENTS TUBES (January 27, 2003)
  • K011699 — VACUETTE EVACUATED BLOOD COLLECTION TUBES (June 28, 2001)

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