510(k) K031359
- Device
- S-MONOVETTE EDTA K2-GEL
- Applicant
- SARSTEDT, INC.
- 510(k) number
- K031359
- Product code
- PJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-12
- Date received
- 2003-04-30
- Regulation
- 862.1675
- Classification name
- Blood/plasma Collection Device For Dna Testing
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER RUMSWINKEL
- Address
- 1025 St. James Church Rd. Newton NC US 28658 28658
FDA Registration Numbers#
- 1058584
- 3010370650
- 3013517171
- 9617475
- 3009732568
- 3013557562
- 3005202328
- 1036836
- 2243072
- 3005674478
- 1423537
- 3003744503
- 1917413
- 1125230
- 3006191977
- 9617032
- 9613662
- 8020040
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PJE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231469 | PAXgene® Blood DNA Tube | Preanalytix GmbH | 2023-06-21 |
| K142821 | PAXgene Blood DNA Tube | Preanalytix GmbH | 2015-09-09 |
| K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | Greiner Bio-One Vacuette North America | 2005-04-15 |
| K014104 | VACUETTE EDTA K2 TUBES | Greiner Vacuette North America, Inc. | 2002-02-01 |
| K012043 | VACUETTE EDTA K2 GEL TUBES | Greiner Vacuette North America, Inc. | 2001-09-24 |
| K010328 | MULTIPLE (IZON DNA BLOOD COLLECTION KIT) | Izon Business Products, Inc. | 2001-04-09 |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Becton Dickinson Vacutainer Systems | 1998-02-24 |
Legacy Summary#
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FDA Review#
Decision Summary