The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Iga Anti-cardiolipin Semi-quantitative Test Kit, Model 026-001.
| Device ID | K022990 |
| 510k Number | K022990 |
| Device Name: | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-09-25 |