Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sangui Biotech, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
293 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001943 | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | Sangui Biotech, Inc. | 2000-08-23 | 58 | 0 |
| K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | Sangui Biotech, Inc. | 2000-06-07 | 293 | 0 |
| K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | Sangui Biotech, Inc. | 1998-09-03 | 48 | 1 |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELIS | Sangui Biotech, Inc. | 1998-08-19 | 23 | 0 |
| K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA | Sangui Biotech, Inc. | 1997-12-23 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda