Yd Diagnostics Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 3 spellings of the applicant name “Yd Diagnostics Corp.” (first 2002, latest 2018), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 133 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 | 1 | 321 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 133 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Yd Diagnostics Corp. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
| KQO | Automated Urinalysis System | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (1)
Most recent Yd Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | JFY | 2018-12-10 | 133 |
| K141874 | URISCAN OPTIMA | KQO | 2015-05-28 | 321 |
| K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | KHE | 2006-09-18 | 165 |
| K050801 | URISCAN OPTIMA II URINE ANALYZER | JIL | 2005-04-20 | 21 |
| K023027 | PREG-Q EARLY PREGNANCY TEST | LCX | 2002-12-16 | 96 |
Recalls
openFDA lists no recalls under a recalling firm named Yd Diagnostics Corp..
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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Yd Diagnostics (2)
- Yd Diagnostics Corp. (2)
- Yd Diagnostics Corporation (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Yd Diagnostics Corp.?
FDA lists 5 510(k) clearances under 3 spellings of the applicant name “Yd Diagnostics Corp.” (first 2002, latest 2018), across 5 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 Yd Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Yd Diagnostics Corp. is 133 days.
Which FDA product codes appear under Yd Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are JFY (Enzymatic Method, Creatinine, 1); JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 1); KHE (Reagent, Occult Blood, 1).
Next steps
- See all 5 Yd Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JFY, Yd Diagnostics Corp.'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.