The following data is part of a premarket notification filed by Gentris Corporation with the FDA for Gentrisure Human Genomic Dna Reference Control.
| Device ID | K063224 |
| 510k Number | K063224 |
| Device Name: | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL |
| Classification | Quality Control Material, Genetics, Dna |
| Applicant | GENTRIS CORPORATION 133 SOUTHCENTER CT. SUITE 400 Morrisville, NC 27560 |
| Contact | Deborah N Kloos |
| Correspondent | Deborah N Kloos GENTRIS CORPORATION 133 SOUTHCENTER CT. SUITE 400 Morrisville, NC 27560 |
| Product Code | NZB |
| CFR Regulation Number | 866.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-24 |
| Decision Date | 2006-12-22 |