S-Monovette Edta K2-GEL
FDA 510(k) K031359 · Sarstedt, Inc.
510(k) numberK031359
Submission
- Device name
- S-Monovette Edta K2-GEL
- Applicant
- Sarstedt, Inc.
Newton, NC, US - Received
- April 30, 2003
- Decision date
- September 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PJE – Blood/Plasma Collection Device For Dna Testing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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 510(k)s with product code PJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231469 | PAXgene® Blood DNA TubePJE · Special | Preanalytix GmbH | 06/21/2023SE |
| K142821 | PAXgene Blood DNA TubePJE · Traditional | Preanalytix GmbH | 09/09/2015SE |
| K042927 | Vacuette Edta K3 Evacuated Blood Collection TubesPJE · Traditional | Greiner Bio-One Vacuette North America | 04/15/2005SE |
| K014104 | Vacuette Edta K2 TubesPJE · Traditional | Greiner Vacuette North America, Inc. | 02/01/2002SE |
| K012043 | Vacuette Edta K2 Gel TubesPJE · Traditional | Greiner Vacuette North America, Inc. | 09/24/2001SE |
| K010328 | Multiple (Izon DNA Blood Collection Kit)PJE · Traditional | Izon Business Products, Inc. | 04/09/2001SE |
| K972075 | Vacutainer Brand PPT Plasma Preparation TubePJE · Traditional | Becton Dickinson Vacutainer Systems | 02/24/1998SE |
More from Becton Dickinson Vacutainer Systems
| 510(k) | Device | Decision |
|---|---|---|
| K222801 | Safety LancetFMK · Traditional | 01/25/2023SE |
| K051019 | Safety NeedleJKA · Traditional | 07/25/2005SE |
| K032150 | Safety-MultiflyFPA · Traditional | 09/12/2003SE |
| K024237 | Urine Monovette Boric AcidJSM · Traditional | 04/14/2003SE |
| K003382 | Sarstedt Needle ProtectorFMI · Traditional | 03/30/2001SE |
| K913622 | HemoplusKHE · Traditional | 01/31/1992SE |
Questions and answers
When was S-Monovette Edta K2-GEL cleared by the FDA?
S-Monovette Edta K2-GEL (K031359) received a 510(k) decision of Substantially Equivalent on September 12, 2003, 135 days after the submission was received.
What is the product code of K031359?
The FDA product code is PJE – Blood/Plasma Collection Device For Dna Testing, a Class II (moderate risk) device regulated under 21 CFR 862.1675.