PAXgene® Blood DNA Tube
FDA 510(k) clearance K231469 · decided 2023-06-21
Clearance details
- K-number
- K231469
- Device name
- PAXgene® Blood DNA Tube
- Applicant
- Preanalytix GmbH
- Decision
- Substantially Equivalent
- Date received
- 2023-05-22
- Decision date
- 2023-06-21
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PJE
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hombrechtikon, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PAXgene Blood DNA Tube (K142821) | Preanalytix GmbH | 2015-09-09 |
| VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (K042927) | Greiner Bio-One Vacuette North America | 2005-04-15 |
| S-MONOVETTE EDTA K2-GEL (K031359) | Sarstedt, Inc. | 2003-09-12 |
| VACUETTE EDTA K2 TUBES (K014104) | Greiner Vacuette North America, Inc. | 2002-02-01 |
| VACUETTE EDTA K2 GEL TUBES (K012043) | Greiner Vacuette North America, Inc. | 2001-09-24 |
| MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (K010328) | Izon Business Products, Inc. | 2001-04-09 |
| VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (K972075) | Becton Dickinson Vacutainer Systems | 1998-02-24 |
Recalls involving this device
No recalls on record reference this clearance.