Serono Laboratories, Inc.: FDA clearances and approvals
Serono Laboratories, Inc. has 10 FDA 510(k) clearances (first 1978, latest 1984), across 9 product codes in 2 review panels. Median 510(k) review time: 38 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 | 1 |
| DHI | Ng3m(Bo), Antigen, Antiserum, Control | 1 | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
| JME | Radioimmunoassay, Glucagon | 1 | 1 |
Review panels
- Clinical Chemistry (9)
- Immunology (1)
Most recent Serono Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | CJM | 1984-03-02 | 78 |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | CHP | 1981-03-31 | 15 |
| K810625 | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- | DHI | 1981-03-27 | 18 |
| K792043 | PAP-CHECK RIA KIT | JFH | 1979-10-30 | 18 |
| K790679 | ESTRADIOL RIA KIT | CHP | 1979-05-23 | 44 |
| K790440 | PROGESTERONE | JLS | 1979-05-03 | 57 |
| K782143 | RIA KIT, GLUCOSE | JME | 1979-02-22 | 57 |
| K782103 | RIA KIT, NEONATAL T4 | CDX | 1979-01-17 | 33 |
| K781733 | RIA KIT, PREG-STAT | JHI | 1978-12-20 | 68 |
| K781285 | INSULIN RIA KIT | CFP | 1978-08-14 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Serono Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Serono Laboratories, Inc. have?
Serono Laboratories, Inc. has 10 FDA 510(k) clearances (first 1978, latest 1984), across 9 product codes in 2 review panels.
How long does FDA take to clear Serono Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Serono Laboratories, Inc.'s cleared 510(k)s is 38 days.
What devices does Serono Laboratories, Inc. make?
Its most frequent FDA product codes are CHP (Radioimmunoassay, Estradiol, 2); CDX (Radioimmunoassay, Total Thyroxine, 1); CFP (Radioimmunoassay, Immunoreactive Insulin, 1).
Has Serono Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Serono Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 10 Serono Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHP, Serono Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.