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510(k) K031359

S-MONOVETTE EDTA K2-GEL by Sarstedt, Inc. — Product Code PJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2003
Date Received
April 30, 2003
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 Sarstedt, Inc.

  • K051019 — SAFETY NEEDLE (July 25, 2005)
  • K032150 — SAFETY-MULTIFLY (September 12, 2003)
  • K024237 — URINE MONOVETTE BORIC ACID (April 14, 2003)
  • K003382 — SARSTEDT NEEDLE PROTECTOR (March 30, 2001)
  • K913622 — HEMOPLUS (January 31, 1992)

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)
  • 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)