The following data is part of a premarket notification filed by Preanalytix Gmbh with the FDA for Paxgene Blood Dna Tube.
| Device ID | K142821 |
| 510k Number | K142821 |
| Device Name: | PAXgene Blood DNA Tube |
| Classification | Blood/plasma Collection Device For Dna Testing |
| Applicant | PREANALYTIX GMBH FELDBACHSTRASSE Hombrechtikon, CH 8634 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato PREANALYTIX GMBH FELDBACHSTRASSE Hombrechtikon, CH 8634 |
| Product Code | PJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-09-09 |
| Summary: | summary |