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510(k) K012043

VACUETTE EDTA K2 GEL TUBES by Greiner Vacuette North America, Inc. — Product Code PJE

K012043 is an FDA 510(k) premarket notification submitted by Greiner Vacuette North America, Inc. for the device "VACUETTE EDTA K2 GEL TUBES". The FDA issued a decision of Substantially Equivalent on September 24, 2001. 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 Vacuette North America, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2001
Date Received
June 29, 2001
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 Vacuette North America, Inc.

  • K014104 — VACUETTE EDTA K2 TUBES (February 1, 2002)
  • K011786 — VACUETTE SAFETY BLOOD COLLECTION SET (July 12, 2001)
  • K003812 — VACUETTE SPEEDY QUICK-RELEASE HOLDER (April 30, 2001)
  • K002777 — VACUETTE WITH PPACK (October 5, 2000)

Other clearances for product code PJE

  • K231469 — PAXgene® Blood DNA Tube (June 21, 2023)
  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (April 15, 2005)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K014104 — VACUETTE EDTA K2 TUBES (February 1, 2002)
  • K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (April 9, 2001)
  • K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (February 24, 1998)

FDA data resources