Ciba Corning Diagnostics Corp.: FDA filings under this applicant name
FDA lists 125 510(k) clearances under the applicant name “Ciba Corning Diagnostics Corp.” (first 1986, latest 1996), across 60 product codes in 6 review panels. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 13 | 13 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 7 | 7 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 7 | 7 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 | 7 |
| CDD | Radioassay, Vitamin B12 | 4 | 4 |
| JGS | Electrode, Ion Specific, Sodium | 4 | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 4 | 4 |
| CDX | Radioimmunoassay, Total Thyroxine | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
Plus 50 more product codes.
Review panels
- Clinical Chemistry (94)
- Immunology (12)
- Clinical Toxicology (12)
- Microbiology (3)
- Anesthesiology (2)
- Hematology (2)
Most recent Ciba Corning Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962559 | ACS CORTISOL IMMUNOASSAY | JFT | 1996-11-05 | 127 |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | JMM | 1996-10-15 | 57 |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | GLK | 1996-07-26 | 77 |
| K961657 | CIBA CORNING 400 SYSTEM | CHL | 1996-06-25 | 56 |
| K962021 | CIBA CORNING 348 SYSTEM | CHL | 1996-06-24 | 32 |
| K962126 | ACS CKMB II IMMUNOASSAY | JHS | 1996-06-21 | 18 |
| K962041 | ACS LH2 IMMUNOASSAY | CEP | 1996-06-21 | 24 |
| K961510 | ACS FRT4 IMMUNOASSAY | JJX | 1996-06-17 | 59 |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | JJT | 1996-04-23 | 98 |
| K955873 | ACS PHENYTOIN ASSAY | LGR | 1996-03-11 | 76 |
115 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ciba Corning Diagnostics Corp..
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.
- Ciba Vision Corporation (44 510(k)s)
- Ciba Vision Care (2 510(k)s)
- Ciba-Geigy Corp. (2 510(k)s)
- Ciba Vision Johns Creek Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ciba Corning Diagnostics Corp.?
FDA lists 125 510(k) clearances under the applicant name “Ciba Corning Diagnostics Corp.” (first 1986, latest 1996), across 60 product codes in 6 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 Ciba Corning Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ciba Corning Diagnostics Corp. is 70 days.
Which FDA product codes appear under Ciba Corning Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 13); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 7); DHB (System, Test, Radioallergosorbent (Rast) Immunological, 7).
Next steps
- See all 125 Ciba Corning Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Ciba Corning Diagnostics Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.