K142821 is an FDA 510(k) clearance for the PAXgene Blood DNA Tube. This device is classified as a Blood/plasma Collection Device For Dna Testing (Class II - Special Controls, product code PJE).
Submitted by Preanalytix GmbH (Hombrechtikon, CH). The FDA issued a Cleared decision on September 9, 2015, 344 days after receiving the submission on September 30, 2014.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1675. A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna Testing..
| 510(k) Number | K142821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2014 |
| Decision Date | September 09, 2015 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | PJE - Blood/plasma Collection Device For Dna Testing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
| Definition | A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna Testing. |