K001943 is an FDA 510(k) clearance for the CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY. This device is classified as a Test, Carbohydrate Deficient Transferrin (Class I - General Controls, product code NAO).
Submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 23, 2000, 58 days after receiving the submission on June 26, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K001943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2000 |
| Decision Date | August 23, 2000 |
| Days to Decision | 58 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 |