Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dexall Biomedical Labs, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K885269 | ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS | Dexall Biomedical Labs, Inc. | 1989-02-07 | 47 | 0 |
| K875066 | ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT | Dexall Biomedical Labs, Inc. | 1988-01-29 | 51 | 0 |
| K864696 | ALLERG*ENS ENZYME IMMUNOASSAY KIT | Dexall Biomedical Labs, Inc. | 1987-03-17 | 106 | 0 |
| K853607 | ALLERG-E IGE ENZYME IMMUNOASSAY KIT | Dexall Biomedical Labs, Inc. | 1985-11-07 | 71 | 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