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 |