Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microbiological Assoc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
162 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K792133 | RUBELISA TEST KIT | Microbiological Assoc. | 1980-01-11 | 81 | 0 |
| K791397 | HERPES EIA TEST KIT | Microbiological Assoc. | 1979-09-24 | 59 | 0 |
| K781549 | TOXELISA TEST KIT | Microbiological Assoc. | 1978-12-07 | 86 | 0 |
| K780996 | RUBELISA TEST KIT | Microbiological Assoc. | 1978-11-22 | 162 | 0 |
| K781392 | CYTOMEGILISH TEST KIT | Microbiological Assoc. | 1978-10-24 | 75 | 0 |
| K781143 | IMMUNOFLUORESCENCE TEST KIT | Microbiological Assoc. | 1978-08-14 | 35 | 0 |
| K770764 | TISSUE CULTURE MEDIA W/HEPES BUFFER | Microbiological Assoc. | 1977-07-21 | 85 | 0 |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Microbiological Assoc. | 1977-06-14 | 62 | 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