The following data is part of a premarket notification filed by Sangui Biotech, Inc. with the FDA for Chronalco I.d.cdt (carbohydrate Deficient Transferrin) Assay.
| Device ID | K001943 |
| 510k Number | K001943 |
| Device Name: | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY |
| Classification | Test, Carbohydrate Deficient Transferrin |
| Applicant | SANGUI BIOTECH, INC. 1508 BROOKHOLLOW DR., #354 Santa Ana, CA 92705 |
| Contact | John J Kiang |
| Correspondent | John J Kiang SANGUI BIOTECH, INC. 1508 BROOKHOLLOW DR., #354 Santa Ana, CA 92705 |
| Product Code | NAO |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-26 |
| Decision Date | 2000-08-23 |