The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Modification To: Reaads Anti-phosphatidylserine Igg/igm Semi-quantitative Test Kit.
| Device ID | K012567 |
| 510k Number | K012567 |
| Device Name: | MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT |
| 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 | 2001-08-09 |
| Decision Date | 2001-08-23 |