Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microanalytic Research, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
94 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861097 | TRYPSIN RIA KIT | Microanalytic Research, Inc. | 1986-05-29 | 66 | 0 |
| K820741 | MR1 LUTROPIN RIA KIT | Microanalytic Research, Inc. | 1982-04-14 | 27 | 0 |
| K820740 | MR1 FOLLITROPIN RIA KIT | Microanalytic Research, Inc. | 1982-04-06 | 19 | 0 |
| K813516 | MRI TOBRAMYCIN RIA KIT | Microanalytic Research, Inc. | 1981-12-29 | 14 | 0 |
| K812394 | MRI GENTAMICIN RIA KIT | Microanalytic Research, Inc. | 1981-09-08 | 19 | 0 |
| K810949 | MRI PROLACTIN RIA KIT | Microanalytic Research, Inc. | 1981-07-10 | 94 | 0 |
| K802754 | IMMUNOREACTIVE ESTRIOL RIA KIT | Microanalytic Research, Inc. | 1981-01-21 | 79 | 0 |
| K801491 | MRI HCG-BETA RIA KIT CAT. #MR-10100 | Microanalytic Research, Inc. | 1980-08-13 | 48 | 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