The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Ii Anti-cardiolipin Igg Semi-quantitative Test Kit, Model 11139.
| Device ID | K032868 |
| 510k Number | K032868 |
| Device Name: | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 |
| 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 |
| Subsequent Product Code | DHC |
| Subsequent Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2003-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855360006199 | K032868 | 000 |
| 00847817018213 | K032868 | 000 |
| 00847817018220 | K032868 | 000 |
| 00847817018237 | K032868 | 000 |
| 00847817018244 | K032868 | 000 |
| 00847817018251 | K032868 | 000 |
| 00847817018268 | K032868 | 000 |
| 00847817018275 | K032868 | 000 |
| 00847817018282 | K032868 | 000 |
| 00855360006069 | K032868 | 000 |
| 00855360006076 | K032868 | 000 |
| 00855360006083 | K032868 | 000 |
| 00855360006113 | K032868 | 000 |
| 00855360006120 | K032868 | 000 |
| 00855360006137 | K032868 | 000 |
| 00855360006175 | K032868 | 000 |
| 00855360006182 | K032868 | 000 |
| 00847817018206 | K032868 | 000 |