Panels › Clinical Chemistry › Product code PJE · Class 2
Blood/Plasma Collection Device For Dna Testing
Regulation 862.1675
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PJE
| Company | 510(k)s | Recalls |
|---|---|---|
| Greiner Vacuette North America, Inc. | 2 | 0 |
| Preanalytix GmbH | 2 | 0 |
| Becton Dickinson Vacutainer Systems | 1 | 0 |
| Greiner Bio-One Vacuette North America | 1 | 0 |
| Izon Business Products, Inc. | 1 | 0 |
| Sarstedt, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2023 | K231469 | PAXgene® Blood DNA Tube Preanalytix GmbH, CH | PJE |
| Sep 9, 2015 | K142821 | PAXgene Blood DNA Tube Preanalytix GmbH, CH | PJE |
| Apr 15, 2005 | K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES Greiner Bio-One Vacuette North America | PJE |
| Sep 12, 2003 | K031359 | S-MONOVETTE EDTA K2-GEL Sarstedt, Inc. | PJE |
| Feb 1, 2002 | K014104 | VACUETTE EDTA K2 TUBES Greiner Vacuette North America, Inc. | PJE |
| Sep 24, 2001 | K012043 | VACUETTE EDTA K2 GEL TUBES Greiner Vacuette North America, Inc. | PJE |
| Apr 9, 2001 | K010328 | MULTIPLE (IZON DNA BLOOD COLLECTION KIT) Izon Business Products, Inc. | PJE |
| Feb 24, 1998 | K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE Becton Dickinson Vacutainer Systems | PJE |
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