The following data is part of a premarket notification filed by Sangui Biotech, Inc. with the FDA for Sangui Biotech, Inc. Epo (erythropoietin) Elisa Kit.
| Device ID | K992799 |
| 510k Number | K992799 |
| Device Name: | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT |
| Classification | Assay, Erythropoietin |
| 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 | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-19 |
| Decision Date | 2000-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24221EPOHUE010 | K992799 | 000 |
| 00840239036469 | K992799 | 000 |
| 00083059070255 | K992799 | 000 |
| 08305900070255 | K992799 | 000 |
| 04048474036466 | K992799 | 000 |