The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Igm Anti-b2gpi Test Kit, Model 038-001.
| Device ID | K031208 |
| 510k Number | K031208 |
| Device Name: | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| 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 | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-07-07 |