Electro-Nucleonics Laboratories, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Electro-Nucleonics Laboratories, Inc.” (first 1976, latest 1988), across 34 product codes in 5 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| KLS | Enzyme Immunoassay, Theophylline | 2 | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
Plus 24 more product codes.
Review panels
- Clinical Chemistry (18)
- Microbiology (11)
- Clinical Toxicology (6)
- Immunology (5)
- Hematology (1)
Most recent Electro-Nucleonics Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873925 | VIRGO(TM) MEASLES IGG ELISA | LJB | 1988-02-24 | 152 |
| K873617 | GEMSTAR II SYSTEM | JJE | 1987-10-19 | 41 |
| K873416 | MULTI-ACCESS REAGENT DISPENSER | JQW | 1987-10-09 | 45 |
| K873358 | GEMENI URIC ACID U.V. | CDO | 1987-09-11 | 21 |
| K873088 | VIRGO(TM) RUBELLA IGG ELISA | LFX | 1987-09-09 | 35 |
| K871905 | TOXOPLASMA GONDII IGG ELISA | LGD | 1987-07-30 | 76 |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | CHH | 1987-04-22 | 44 |
| K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES | CDT | 1986-11-13 | 41 |
| K862640 | AMYLASE LTS | CJA | 1986-09-09 | 61 |
| K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT | KLS | 1985-09-04 | 23 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electro-Nucleonics Laboratories, 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.
- Electro-Nucleonics, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electro-Nucleonics Laboratories, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Electro-Nucleonics Laboratories, Inc.” (first 1976, latest 1988), across 34 product codes in 5 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 Electro-Nucleonics Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electro-Nucleonics Laboratories, Inc. is 44 days.
Which FDA product codes appear under Electro-Nucleonics Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 3); JQW (Station, Pipetting And Diluting, For Clinical Use, 3); CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt, 2).
Next steps
- See all 41 Electro-Nucleonics Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJE, Electro-Nucleonics Laboratories, 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.