Logos Scientific, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Logos Scientific, Inc.” (first 1984, latest 1990), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| JJN | Apparatus, Electrophoresis, For Clinical Use | 3 | 3 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| JJO | Flame Emission Photometer For Clinical Use | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| KQG | Instrument, Coagulation | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Hematology (1)
Most recent Logos Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902614 | ELVI 828 DIGICLOT MULTISCAN | KQG | 1990-11-08 | 148 |
| K843375 | ELVI 655 FLAME PHOTOMETER | JJO | 1985-05-20 | 265 |
| K844710 | EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD | JJN | 1985-01-07 | 35 |
| K843296 | ELVI 675 DIGITRON | JJQ | 1984-09-13 | 23 |
| K842313 | ELVI 146 SEROSCAN | JQT | 1984-09-10 | 90 |
| K842056 | ELVI 165 PROTEO SEROSKOP | JQT | 1984-06-22 | 31 |
| K841804 | ELVI 70 SAFETY CHAMBER | JJN | 1984-05-31 | 30 |
| K840757 | ELVI 444 BILITRON | CIG | 1984-05-30 | 97 |
| K841288 | ELVI 18 | JJN | 1984-05-02 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Logos Scientific, 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.
- Logos Medical Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Logos Scientific, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Logos Scientific, Inc.” (first 1984, latest 1990), across 6 product codes in 2 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 Logos Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Logos Scientific, Inc. is 35 days.
Which FDA product codes appear under Logos Scientific, Inc.?
The most frequent FDA product codes under this applicant name are JJN (Apparatus, Electrophoresis, For Clinical Use, 3); JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica, 2); CIG (Diazo Colorimetry, Bilirubin, 1).
Next steps
- See all 9 Logos Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJN, Logos Scientific, 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 (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.