The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Igg Anti-atherox Test Kit.
| Device ID | K072032 |
| 510k Number | K072032 |
| Device Name: | IGG ANTI-ATHEROX TEST KIT |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | CORGENIX, INC. 11575 MAIN ST. SUITE 400 Broomfield, CO 80020 |
| Contact | Daniel F Simpson |
| Correspondent | Daniel F Simpson CORGENIX, INC. 11575 MAIN ST. SUITE 400 Broomfield, CO 80020 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-24 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855360006236 | K072032 | 000 |