The following data is part of a premarket notification filed by Axis with the FDA for Axis %cdt Turbidimetric Immunoassay.
| Device ID | K992502 |
| 510k Number | K992502 |
| Device Name: | AXIS %CDT TURBIDIMETRIC IMMUNOASSAY |
| Classification | Test, Carbohydrate Deficient Transferrin |
| Applicant | AXIS PO BOX 262069 San Diego, CA 92196 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi AXIS PO BOX 262069 San Diego, CA 92196 |
| Product Code | NAO |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-26 |
| Decision Date | 1999-12-21 |
| Summary: | summary |