Paragon Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Paragon Diagnostics, Inc.” (first 1984, latest 1984), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| JZT | Fluorometer | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 | 1 |
| LCQ | Fluorescent Immunoassay Gentamicin | 1 | 1 |
| LCR | Fluorescent Immunoassay, Tobramycin | 1 | 1 |
| LER | Fluorescent Immunoassay, Theophylline | 1 | 1 |
Review panels
- Clinical Toxicology (4)
- Clinical Chemistry (2)
- Immunology (1)
Most recent Paragon Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841162 | IMMPULSE GENTAMICIN ASSAY REAGENTS | LCQ | 1984-05-02 | 44 |
| K841161 | IMMPULSE AMIKACIN ASSAY REAGENTS | KLQ | 1984-05-02 | 44 |
| K840852 | IMMPULSE T4 ASSAY REAGENTS | CDX | 1984-04-18 | 54 |
| K840847 | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | LCR | 1984-04-04 | 40 |
| K840758 | IMMPULSE THEOPHYLLINE ASSAY REAGENTS | LER | 1984-04-04 | 41 |
| K840853 | IMMPULSE TBC ASSAY REAGENTS | KHQ | 1984-04-01 | 37 |
| K834070 | IMMPULSE SYSTEM | JZT | 1984-03-23 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Paragon Diagnostics, 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.
- Paragon 28, Inc. (60 510(k)s)
- Paragon Vision Sciences (16 510(k)s)
- Paragon Trade Brands, Inc. (14 510(k)s)
- Paragon Implant Mfg., LLC (5 510(k)s)
- Paragon Medical (5 510(k)s)
- Paragon Optical Co. (1 510(k)s)
- Paragon Bioteck, Inc. (1 510(k)s)
- Paragon Medical and Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paragon Diagnostics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Paragon Diagnostics, Inc.” (first 1984, latest 1984), across 7 product codes in 3 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 Paragon Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon Diagnostics, Inc. is 44 days.
Which FDA product codes appear under Paragon Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CDX (Radioimmunoassay, Total Thyroxine, 1); JZT (Fluorometer, 1); KHQ (Radioassay, Triiodothyronine Uptake, 1).
Next steps
- See all 7 Paragon Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDX, Paragon Diagnostics, 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.