Serono Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Serono Diagnostics, Inc.” (first 1984, latest 1996), across 19 product codes in 3 review panels. Median 510(k) review time under this name: 55 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 | 1 |
| GKZ | Counter, Differential Cell | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (19)
- Microbiology (4)
- Hematology (1)
Most recent Serono Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | GKZ | 1996-03-11 | 223 |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | JKC | 1994-07-13 | 76 |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | KHQ | 1988-09-09 | 49 |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | CEP | 1988-08-08 | 62 |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | CDP | 1988-03-03 | 35 |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | KLI | 1988-02-11 | 76 |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | JLS | 1987-10-20 | 55 |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | CEP | 1987-09-29 | 48 |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | CFT | 1987-09-25 | 32 |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | CFT | 1987-09-18 | 59 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Serono Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Serono Laboratories, Inc. (10 510(k)s)
- Serono, Inc. (1 510(k)s)
- Serono Baker Diagnostics System (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Serono Diagnostics, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Serono Diagnostics, Inc.” (first 1984, latest 1996), across 19 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Serono Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Serono Diagnostics, Inc. is 55 days.
Which FDA product codes appear under Serono Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 3); CFT (Radioimmunoassay, Prolactin (Lactogen), 2); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 2).
Next steps
- See all 25 Serono Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Serono Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.