The following data is part of a premarket notification filed by Sangui Biotech, Inc. with the FDA for Sangui Biotech, Inc. Intact-pth (parathyroid Hormone) Elisa.
| Device ID | K974306 |
| 510k Number | K974306 |
| Device Name: | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| 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 | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1997-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24221IPTHUE010 | K974306 | 000 |
| 08305900070224 | K974306 | 000 |
| 00840239036452 | K974306 | 000 |
| 00083059070224 | K974306 | 000 |
| 04048474036459 | K974306 | 000 |