Home / 510(k) Clearances / K031359

510(k) K031359

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

K031359 is an FDA 510(k) premarket notification submitted by Sarstedt, Inc. for the device "S-MONOVETTE EDTA K2-GEL". The FDA issued a decision of Substantially Equivalent on September 12, 2003. The device falls under product code PJE (Blood/Plasma Collection Device For Dna Testing), a Class II device regulated under 21 CFR 862.1675. Sarstedt, Inc. has at least 5 other 510(k) clearances on record.

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)

FDA data resources