Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Parasitic Disease Consultants · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830870 | POLYCHACO INDIRECT HEMAGGLUTINATION | Parasitic Disease Consultants | 1983-08-12 | 147 | 0 |
| K830869 | POLYCHACO INDIRECT IMMUNOFLUORESCENCE | Parasitic Disease Consultants | 1983-08-11 | 146 | 0 |
| K831296 | POLYCHACO FIA-ABS TEST FOR SYPHILIS | Parasitic Disease Consultants | 1983-07-26 | 97 | 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