K992502 is an FDA 510(k) clearance for the AXIS %CDT TURBIDIMETRIC IMMUNOASSAY. This device is classified as a Test, Carbohydrate Deficient Transferrin (Class I - General Controls, product code NAO).
Submitted by Axis (San Diego, US). The FDA issued a Cleared decision on December 21, 1999, 148 days after receiving the submission on July 26, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K992502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1999 |
| Decision Date | December 21, 1999 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NAO — Test, Carbohydrate Deficient Transferrin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |