Corning Medical & Scientific: FDA filings under this applicant name
FDA lists 111 510(k) clearances under the applicant name “Corning Medical & Scientific” (first 1976, latest 1988), across 65 product codes in 8 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 7 | 7 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 4 | 4 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 4 | 4 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 4 | 4 |
| CDD | Radioassay, Vitamin B12 | 3 | 3 |
| CEC | Radioimmunoassay, Free Thyroxine | 3 | 3 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 3 | 3 |
| CGR | Radioimmunoassay, Cortisol | 3 | 3 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 3 | 3 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 3 | 3 |
Plus 55 more product codes.
Review panels
- Clinical Chemistry (81)
- Hematology (8)
- Pathology (7)
- Immunology (5)
- Microbiology (5)
- Clinical Toxicology (2)
- Anesthesiology (1)
- Ophthalmic (1)
Most recent Corning Medical & Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | KET | 1988-01-12 | 28 |
| K872273 | CORNING EASY WASH ELISA PLATES | LIB | 1987-07-07 | 22 |
| K872076 | CORNING DISPOSABLE ROLLER BOTTLES | KJB | 1987-06-15 | 17 |
| K863789 | CORNING ELISA PLATES | LIB | 1986-10-03 | 7 |
| K854024 | CORNING MAGIC MAB HCG RADIOIMMUNOASSAY | JHI | 1985-11-26 | 57 |
| K853634 | CORNING CELL WELLS-MULTIPLE WELL PLATES | KIZ | 1985-09-16 | 17 |
| K851939 | CORNING CERTAIN -ISE | JIX | 1985-06-14 | 42 |
| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | JLW | 1985-06-13 | 70 |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | GIO | 1985-03-25 | 26 |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | JQT | 1985-03-12 | 25 |
101 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Corning Medical & Scientific.
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.
- Corning Costar Corp. (8 510(k)s)
- Corning Nichols Diagnostics (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Corning Medical & Scientific?
FDA lists 111 510(k) clearances under the applicant name “Corning Medical & Scientific” (first 1976, latest 1988), across 65 product codes in 8 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 Corning Medical & Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corning Medical & Scientific is 37 days.
Which FDA product codes appear under Corning Medical & Scientific?
The most frequent FDA product codes under this applicant name are JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 7); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 4); JHX (Fluorometric Method, Cpk Or Isoenzymes, 4).
Next steps
- See all 111 Corning Medical & Scientific clearances with predicates and recalls
- Run predicate analysis for product code JLW, Corning Medical & Scientific'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.