The following data is part of a premarket notification filed by Preanalytix Gmbh with the FDA for Modification To Paxgene Blood Rna System.
| Device ID | K082150 |
| 510k Number | K082150 |
| Device Name: | MODIFICATION TO PAXGENE BLOOD RNA SYSTEM |
| Classification | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test |
| Applicant | PREANALYTIX GMBH 1 BECTON DRIVE MC 300 Franklin Lakes, NJ 07417 |
| Contact | Wendy Ballesteros |
| Correspondent | Wendy Ballesteros PREANALYTIX GMBH 1 BECTON DRIVE MC 300 Franklin Lakes, NJ 07417 |
| Product Code | NTW |
| CFR Regulation Number | 866.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2009-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54053727621653 | K082150 | 000 |
| 04053727621658 | K082150 | 000 |