Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M.A. Bioproducts — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
159 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K822883 | HERPELISA KIT | M.A. Bioproducts | 1983-07-26 | 306 | 0 |
| K823804 | MYCOPLASMELISA TEST KIT | M.A. Bioproducts | 1983-05-25 | 159 | 0 |
| K830045 | MUMPSELISA TEST KIT | M.A. Bioproducts | 1983-05-13 | 123 | 0 |
| K830615 | CYTOMEGELISA STAT | M.A. Bioproducts | 1983-05-09 | 70 | 0 |
| K823805 | VARICELISA TEST KIT | M.A. Bioproducts | 1983-05-05 | 139 | 0 |
| K821967 | CHLAMYDELISA TEST KIT | M.A. Bioproducts | 1982-08-03 | 32 | 0 |
| K821762 | MEASELISA TEST KIT | M.A. Bioproducts | 1982-07-30 | 45 | 0 |
| K813221 | TOXOELISA TEST KIT | M.A. Bioproducts | 1982-01-26 | 78 | 0 |
| K812531 | CELL CULTURE REAGENTS | M.A. Bioproducts | 1981-10-23 | 51 | 0 |
| K812123 | CYTOMEGELISA TEST KIT | M.A. Bioproducts | 1981-09-23 | 58 | 0 |
| K802508 | RUBELISA IGM TEST KIT | M.A. Bioproducts | 1980-12-18 | 64 | 0 |
| K801490 | DIGOXIN EIA KIT | M.A. Bioproducts | 1980-07-14 | 18 | 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