Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serono Laboratories, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
78 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1984-03-02 | 78 | 0 |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1981-03-31 | 15 | 0 |
| K810625 | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- | Serono Laboratories, Inc. | 1981-03-27 | 18 | 0 |
| K792043 | PAP-CHECK RIA KIT | Serono Laboratories, Inc. | 1979-10-30 | 18 | 0 |
| K790679 | ESTRADIOL RIA KIT | Serono Laboratories, Inc. | 1979-05-23 | 44 | 0 |
| K790440 | PROGESTERONE | Serono Laboratories, Inc. | 1979-05-03 | 57 | 0 |
| K782143 | RIA KIT, GLUCOSE | Serono Laboratories, Inc. | 1979-02-22 | 57 | 0 |
| K782103 | RIA KIT, NEONATAL T4 | Serono Laboratories, Inc. | 1979-01-17 | 33 | 0 |
| K781733 | RIA KIT, PREG-STAT | Serono Laboratories, Inc. | 1978-12-20 | 68 | 0 |
| K781285 | INSULIN RIA KIT | Serono Laboratories, Inc. | 1978-08-14 | 19 | 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