Cenogenics Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cenogenics Corp.” (first 1985, latest 2005), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | 1 |
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Microbiology (1)
Most recent Cenogenics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042641 | CHEMVIEW-10 | JIL | 2005-01-07 | 102 |
| K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | LCX | 2003-04-17 | 62 |
| K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | JHI | 1999-08-26 | 38 |
| K894793 | MONODEX | KTN | 1989-08-21 | 24 |
| K843680 | URI-VAL | JMZ | 1985-03-29 | 192 |
Recalls
openFDA lists no recalls under a recalling firm named Cenogenics 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cenogenics Corp.?
FDA lists 5 510(k) clearances under the applicant name “Cenogenics Corp.” (first 1985, latest 2005), 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 Cenogenics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cenogenics Corp. is 62 days.
Which FDA product codes appear under Cenogenics Corp.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 1); JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 1); JMZ (Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality, 1).
Next steps
- See all 5 Cenogenics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Cenogenics 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, 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.