Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alexon Biomedical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
329 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964864 | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1997-02-04 | 62 | 0 |
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1996-02-09 | 88 | 2 |
| K936191 | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY | Alexon Biomedical, Inc. | 1994-11-17 | 329 | 0 |
| K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1993-11-22 | 97 | 0 |
| K874849 | PROSPECT/GIARDIA | Alexon Biomedical, Inc. | 1988-01-05 | 41 | 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