Para Scientific Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Para Scientific Co.” (first 1985, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| LKS | Device, Parasite Concentration | 3 | 3 |
| LIO | Device, Specimen Collection | 2 | 2 |
Review panels
- Microbiology (5)
Most recent Para Scientific Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021420 | PARACON II/FECAL CONCENTRATOR II | LKS | 2002-06-04 | 32 |
| K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF | LIO | 1996-11-27 | 41 |
| K881649 | MODIFIED PARACON(TM) CONCENTRATION KIT | LKS | 1988-04-21 | 6 |
| K872751 | FLUORTRAN - C(TM) | LIO | 1987-07-23 | 10 |
| K853715 | PARA CON TM | LKS | 1985-10-02 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Para Scientific Co..
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 Para Scientific Co.?
FDA lists 5 510(k) clearances under the applicant name “Para Scientific Co.” (first 1985, latest 2002), across 2 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 Para Scientific Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Para Scientific Co. is 28 days.
Which FDA product codes appear under Para Scientific Co.?
The most frequent FDA product codes under this applicant name are LKS (Device, Parasite Concentration, 3); LIO (Device, Specimen Collection, 2).
Next steps
- See all 5 Para Scientific Co. clearances with predicates and recalls
- Run predicate analysis for product code LKS, Para Scientific Co.'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.