E-Y Laboratories, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “E-Y Laboratories, Inc.” (first 1983, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 228 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 11 | 11 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
Review panels
- Microbiology (13)
Most recent E-Y Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934130 | SWABZYME OXIDASE | JTO | 1994-09-14 | 394 |
| K940162 | GONOCHEK II REAGENT TUBES | JTO | 1994-09-09 | 240 |
| K940161 | B-LACTAMASE REAGENT TUBES | JTO | 1994-09-09 | 240 |
| K934125 | GONOCHEK-II, MODIFICATION | JTO | 1994-09-09 | 393 |
| K940124 | EY-20 REAGENT TUBES | JTO | 1994-08-26 | 228 |
| K940020 | STREP-A-CHEK(TM) REAGENT STRIPS | JTO | 1994-08-26 | 235 |
| K934129 | STREP-A-CHEK | JTO | 1994-08-26 | 379 |
| K844276 | E-COLI-CHEK TUBE | JTO | 1984-12-13 | 38 |
| K842600 | STREP-A-CHEK | JSF | 1984-07-11 | 8 |
| K840810 | SWABZYME-OXIDASE | JTO | 1984-04-04 | 61 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named E-Y 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under E-Y Laboratories, Inc.?
FDA lists 13 510(k) clearances under the applicant name “E-Y Laboratories, Inc.” (first 1983, latest 1994), across 3 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 E-Y Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name E-Y Laboratories, Inc. is 228 days.
Which FDA product codes appear under E-Y Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 11); JSF (Culture Media, Single Biochemical Test, 1); JSX (Kit, Identification, Neisseria Gonorrhoeae, 1).
Next steps
- See all 13 E-Y Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTO, E-Y 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.