510(k) K142821
- Device
- PAXgene Blood DNA Tube
- Applicant
- PREANALYTIX GMBH
- 510(k) number
- K142821
- Product code
- PJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-09
- Date received
- 2014-09-30
- Regulation
- 862.1675
- Classification name
- Blood/plasma Collection Device For Dna Testing
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Pasquale Amato
- Address
- Feldbachstrasse Hombrechtikon CH 8634 8634
FDA Registration Numbers#
- 1058584
- 3010370650
- 3013517171
- 9617475
- 3009732568
- 3013557562
- 3005202328
- 1036836
- 2243072
- 3005674478
- 1423537
- 3003744503
- 1917413
- 1125230
- 3006191977
- 9617032
- 9613662
- 8020040
Source Documents#
Other 510(k) Records For Product Code PJE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231469 | PAXgene® Blood DNA Tube | Preanalytix GmbH | 2023-06-21 |
| K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | Greiner Bio-One Vacuette North America | 2005-04-15 |
| K031359 | S-MONOVETTE EDTA K2-GEL | Sarstedt, Inc. | 2003-09-12 |
| 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#
summary
FDA Review#
Decision Summary