The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Igm Anti-prothrombin Semi-quantitative Test Kit.
| Device ID | K001398 |
| 510k Number | K001398 |
| Device Name: | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT |
| Classification | System, Test, Systemic Lupus Erythematosus |
| 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 | DHC |
| CFR Regulation Number | 866.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-03 |
| Decision Date | 2001-03-30 |