Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alexon, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
370 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934493 | PROSPECT MICROPLATE ASSAY | Alexon, Inc. | 1994-09-20 | 370 | 0 |
| K942098 | PROSPECT GIARDIA | Alexon, Inc. | 1994-09-09 | 148 | 0 |
| K931147 | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION | Alexon, Inc. | 1993-05-13 | 69 | 0 |
| K930451 | PROSPEC T GIARDIA MICROTITER ASSAY | Alexon, Inc. | 1993-04-21 | 84 | 0 |
| K922675 | PROSPECT GIARDIA CONTROLS | Alexon, Inc. | 1992-09-11 | 99 | 0 |
| K922010 | PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION | Alexon, Inc. | 1992-06-19 | 50 | 0 |
| K920817 | MODIFICATION PROSPECT GIARDIA RAPID ASSAY | Alexon, Inc. | 1992-04-22 | 76 | 0 |
| K912242 | PROSPECT(TM/CRYPTOSPORIDIUM | Alexon, Inc. | 1992-03-23 | 307 | 0 |
| K915093 | PROSPECT(TM) GIARDIA RAPID ASSAY | Alexon, Inc. | 1992-01-30 | 79 | 0 |
| K911337 | PROSPEC T/GIARDIA RAPID ASSAY | Alexon, Inc. | 1991-09-27 | 185 | 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