The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Dsdna Quantitative Test Kit, Model 022-001.
| Device ID | K034013 |
| 510k Number | K034013 |
| Device Name: | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | CORGENIX, INC. 12061 TEJON ST. Westminster, CO 80234 |
| Contact | Nanci Dexter |
| Correspondent | Nanci Dexter CORGENIX, INC. 12061 TEJON ST. Westminster, CO 80234 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-01-08 |