Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genbio — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
299 daysmedian FDA review time
314 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010301 | IMMUNOWELL EA (D) IGG TEST | Genbio | 2001-06-11 | 130 | 0 |
| K974226 | IMMUNODOT MONO-G TEST | Genbio | 1998-09-22 | 314 | 0 |
| K974244 | IMMUNODOT MONO-M TEST | Genbio | 1998-09-22 | 314 | 0 |
| K973939 | IMMUNOWELL VCA IGM TEST | Genbio | 1998-08-10 | 299 | 0 |
| K973940 | IMMUNOWELL EBV VCA IGG TEST | Genbio | 1998-08-10 | 299 | 0 |
| K973941 | IMMUNOWELL EBNA IGG TEST | Genbio | 1998-08-10 | 299 | 0 |
| K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | Genbio | 1997-05-05 | 272 | 0 |
| K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | Genbio | 1997-05-02 | 269 | 0 |
| K953682 | IMMUNO DOT BORRELIA DOT BLOT G TEST | Genbio | 1996-05-03 | 270 | 0 |
| K953683 | MMUNO DOT BORRELIA DOT BLOT M TEST | Genbio | 1996-05-03 | 270 | 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