Troy Biologicals, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Troy Biologicals, Inc.” (first 1981, latest 1986), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 4 | 4 |
| JSJ | Culture Media, Selective And Non-Differential | 4 | 4 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 2 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (12)
Most recent Troy Biologicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861301 | BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 | JTZ | 1986-04-21 | 14 |
| K832863 | STREP ID QUAD | JSI | 1983-09-26 | 34 |
| K832862 | TRANSGROW MEDIUM | JTY | 1983-09-26 | 34 |
| K832861 | SABOURAUD DEXTROSE AGAR | JSJ | 1983-09-26 | 34 |
| K832860 | SXT BLOOD AGAR | JSJ | 1983-09-26 | 34 |
| K823311 | COLUMBIA V AGAR W/5% HUMAN BLOOD | JSH | 1982-12-15 | 40 |
| K823310 | STREPTOCOCCUS SELECTIVE AGAR | JSI | 1982-12-15 | 40 |
| K823307 | CAMPYLOBACTER SELECTIVE AGAR | JSI | 1982-12-15 | 40 |
| K823306 | HEMOPHILUS QUAD 10 PLATE | JSI | 1982-12-15 | 40 |
| K823309 | MARTIN & LEMIS AGAR W/VCAT INHIBITOR | JTY | 1982-12-03 | 28 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Troy Biologicals, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Troy Biologicals, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Troy Biologicals, Inc.” (first 1981, latest 1986), across 5 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 Troy Biologicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Troy Biologicals, Inc. is 34 days.
Which FDA product codes appear under Troy Biologicals, Inc.?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 4); JSJ (Culture Media, Selective And Non-Differential, 4); JTY (Culture Media, For Isolation Of Pathogenic Neisseria, 2).
Next steps
- See all 12 Troy Biologicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSI, Troy Biologicals, 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.