FDA Product Code
FDA Product Code PJE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1675
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231469 | PAXgene® Blood DNA Tube | Preanalytix GmbH | 2023-06-21 | Special | PDF ↗ |
| K142821 | PAXgene Blood DNA Tube | Preanalytix GmbH | 2015-09-09 | Traditional | PDF ↗ |
| K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | Greiner Bio-One Vacuette North America | 2005-04-15 | Traditional | PDF ↗ |
| K031359 | S-MONOVETTE EDTA K2-GEL | Sarstedt, Inc. | 2003-09-12 | Traditional | PDF ↗ |
| K014104 | VACUETTE EDTA K2 TUBES | Greiner Vacuette North America, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K012043 | VACUETTE EDTA K2 GEL TUBES | Greiner Vacuette North America, Inc. | 2001-09-24 | Traditional | PDF ↗ |
| K010328 | MULTIPLE (IZON DNA BLOOD COLLECTION KIT) | Izon Business Products, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Becton Dickinson Vacutainer Systems | 1998-02-24 | Traditional | PDF ↗ |
Product code PJE · Class II · Clinical Chemistry. Data: openFDA.