Home / 510(k) Clearances / K042927

510(k) K042927

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES by Greiner Bio-One Vacuette North America — Product Code PJE

K042927 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Vacuette North America for the device "VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES". The FDA issued a decision of Substantially Equivalent on April 15, 2005. The device falls under product code PJE (Blood/Plasma Collection Device For Dna Testing), a Class II device regulated under 21 CFR 862.1675. Greiner Bio-One Vacuette North America has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2005
Date Received
October 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood/Plasma Collection Device For Dna Testing
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

Other clearances by Greiner Bio-One Vacuette North America

  • K080235 — SAFETY INFUSION SET (April 24, 2008)
  • K033478 — VACUETTE QUICKSHIELD SAFETY TUBE HOLDER (December 29, 2003)
  • K023971 — VACUETTE TRACE ELEMENTS TUBES (January 27, 2003)
  • K011699 — VACUETTE EVACUATED BLOOD COLLECTION TUBES (June 28, 2001)

Other clearances for product code PJE

  • K231469 — PAXgene® Blood DNA Tube (June 21, 2023)
  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K014104 — VACUETTE EDTA K2 TUBES (February 1, 2002)
  • K012043 — VACUETTE EDTA K2 GEL TUBES (September 24, 2001)
  • K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (April 9, 2001)
  • K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (February 24, 1998)

FDA data resources