New Horizons Diagnostics Co.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “New Horizons Diagnostics Co.” (first 1982, latest 1995), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| LIC | Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae | 3 | 3 |
| GSQ | Antiserum, Vibrio Cholerae, All Varieties | 2 | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 | 2 |
| GMQ | Antigens, Nontreponemal, All | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
Review panels
- Microbiology (10)
Most recent New Horizons Diagnostics Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932622 | CHOLERA SMART(TM) | GSQ | 1995-06-27 | 756 |
| K925190 | PYLORISCREEN | LYR | 1993-03-23 | 160 |
| K922432 | CHOLERASCREEN | GSQ | 1992-12-07 | 199 |
| K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST | GTZ | 1988-02-19 | 92 |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | GMQ | 1987-05-28 | 62 |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | LIC | 1987-05-13 | 55 |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | JXA | 1986-06-30 | 21 |
| K851132 | LATEX AGGLUTINATION TEST | GTZ | 1985-07-05 | 106 |
| K821362 | IMPROVED GONO GEN | LIC | 1982-08-04 | 89 |
| K820007 | NEISSERIA GONORRHOEAE TEST | LIC | 1982-01-29 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named New Horizons Diagnostics 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 New Horizons Diagnostics Co.?
FDA lists 10 510(k) clearances under the applicant name “New Horizons Diagnostics Co.” (first 1982, latest 1995), across 6 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 New Horizons Diagnostics Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New Horizons Diagnostics Co. is 90 days.
Which FDA product codes appear under New Horizons Diagnostics Co.?
The most frequent FDA product codes under this applicant name are LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae, 3); GSQ (Antiserum, Vibrio Cholerae, All Varieties, 2); GTZ (Antisera, All Groups, Streptococcus Spp., 2).
Next steps
- See all 10 New Horizons Diagnostics Co. clearances with predicates and recalls
- Run predicate analysis for product code LIC, New Horizons Diagnostics 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.