Sangui Biotech, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sangui Biotech, Inc.” (first 1997, latest 2000), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| GGT | Assay, Erythropoietin | 1 | 1 |
| JKR | Radioimmunoassay, Calcitonin | 1 | 1 |
| NAO | Test, Carbohydrate Deficient Transferrin | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (1)
Most recent Sangui Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001943 | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | NAO | 2000-08-23 | 58 |
| K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | GGT | 2000-06-07 | 293 |
| K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | JKR | 1998-09-03 | 48 |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | CKG | 1998-08-19 | 23 |
| K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA | CEW | 1997-12-23 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Sangui Biotech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sangui Biotech, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sangui Biotech, Inc.” (first 1997, latest 2000), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sangui Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sangui Biotech, Inc. is 48 days.
Which FDA product codes appear under Sangui Biotech, Inc.?
The most frequent FDA product codes under this applicant name are CEW (Radioimmunoassay, Parathyroid Hormone, 1); CKG (Radioimmunoassay, Acth, 1); GGT (Assay, Erythropoietin, 1).
Next steps
- See all 5 Sangui Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEW, Sangui Biotech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.