Electro-Nucleonics, Inc.: FDA clearances and approvals
Electro-Nucleonics, Inc. has 9 FDA 510(k) clearances (first 1988, latest 1989), across 8 product codes in 2 review panels. Median 510(k) review time: 201 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 |
|---|---|---|---|
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | 2 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 | 1 |
| GQX | Antiserum, Cf, Varicella-Zoster | 1 | 1 |
Review panels
- Microbiology (5)
- Clinical Chemistry (4)
Most recent Electro-Nucleonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893718 | DELTATEST (R) LIPASE II | CET | 1989-09-28 | 134 |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | GNP | 1989-04-28 | 253 |
| K883427 | VIRGO(R) VZV-IGG ELISA | GQX | 1989-03-10 | 207 |
| K883282 | VIRGO HSV-1 IGG ELISA | GQO | 1989-03-10 | 219 |
| K883281 | VIRGO HSV-2 IGG ELISA | GQO | 1989-03-10 | 219 |
| K883102 | VIRGO (R) CMV-IGG ELISA | GQI | 1989-02-08 | 201 |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | CKD | 1988-12-29 | 44 |
| K883206 | LACTATE DEHYDROGENASE LDH | CFJ | 1988-09-09 | 43 |
| K883205 | ALTLTS ALANINE AMINO TRANSFERASE ALT | CKA | 1988-09-09 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Electro-Nucleonics, 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 Electro-Nucleonics, Inc. have?
Electro-Nucleonics, Inc. has 9 FDA 510(k) clearances (first 1988, latest 1989), across 8 product codes in 2 review panels.
How long does FDA take to clear Electro-Nucleonics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Electro-Nucleonics, Inc.'s cleared 510(k)s is 201 days.
What devices does Electro-Nucleonics, Inc. make?
Its most frequent FDA product codes are GQO (Antisera, Cf, Herpesvirus Hominis 1,2, 2); CET (Olive Oil Emulsion (Turbidimetric), Lipase, 1); CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 1).
Has Electro-Nucleonics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Electro-Nucleonics, Inc. Related entities may recall under other names.
Next steps
- See all 9 Electro-Nucleonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GQO, Electro-Nucleonics, 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.