Litton Bionetics: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Litton Bionetics” (first 1978, latest 1984), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| GLZ | Antigens, If, Toxoplasma Gondii | 3 | 3 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 2 | 2 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 2 | 2 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 | 2 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 2 | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 | 1 |
Review panels
- Microbiology (15)
Most recent Litton Bionetics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840417 | EBNA ACIF KIT | LLM | 1984-12-27 | 331 |
| K834443 | ROTAVIRUS BIO-ENZABEAD SCREEN KIT | LIQ | 1984-03-16 | 91 |
| K831343 | CMV RQ BIO-ENZABEAD KIT | LFZ | 1983-08-08 | 105 |
| K822985 | EBV-M KIT | JRY | 1982-12-03 | 52 |
| K821804 | RUBELLA RQ BIO-ENZABEAD KIT | LFX | 1982-09-14 | 89 |
| K801722 | CMV BIO-BEAD TITRATION KIT | GQH | 1980-09-16 | 55 |
| K801721 | HSV BIO-BEAD TITRATION KIT | GQN | 1980-09-16 | 55 |
| K801720 | TOXO BIO-BEAD TITRATION KIT | GLZ | 1980-09-16 | 55 |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | GOL | 1980-06-30 | 83 |
| K791618 | TORCH BIO-BEAD SCREEN KIT | GLZ | 1979-11-13 | 85 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Litton Bionetics.
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.
- Litton Medical Electronics (38 510(k)s)
- Litton Dental Products (12 510(k)s)
- Litton Medical Systems (8 510(k)s)
- Litton Datamedix (5 510(k)s)
- Litton Systems, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Litton Bionetics?
FDA lists 15 510(k) clearances under the applicant name “Litton Bionetics” (first 1978, latest 1984), across 9 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Litton Bionetics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Litton Bionetics is 84 days.
Which FDA product codes appear under Litton Bionetics?
The most frequent FDA product codes under this applicant name are GLZ (Antigens, If, Toxoplasma Gondii, 3); GOL (Antigen, Ha (Including Ha Control), Rubella, 2); GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus, 2).
Next steps
- See all 15 Litton Bionetics clearances with predicates and recalls
- Run predicate analysis for product code GLZ, Litton Bionetics'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.