Culture Kits, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Culture Kits, Inc.” (first 1985, latest 1991), across 6 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 3 | 3 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 2 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
Review panels
- Microbiology (9)
Most recent Culture Kits, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911846 | URI-THREE(TM), MODIFICATION | JXA | 1991-10-04 | 169 |
| K854672 | CANDI-KIT TM | JSI | 1986-07-11 | 232 |
| K853488 | STAPH KIT | JSI | 1985-08-28 | 8 |
| K851225 | URINE DUO | JTZ | 1985-08-13 | 140 |
| K852582 | GONI-KIT | JSX | 1985-07-12 | 24 |
| K852480 | DERM-KIT | JSI | 1985-07-09 | 28 |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | JTZ | 1985-04-29 | 14 |
| K850765 | STREP-KIT | JSJ | 1985-04-24 | 58 |
| K850998 | URI-KIT | JSG | 1985-04-01 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Culture Kits, 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 Culture Kits, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Culture Kits, Inc.” (first 1985, latest 1991), 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 Culture Kits, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Culture Kits, Inc. is 28 days.
Which FDA product codes appear under Culture Kits, Inc.?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 3); JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, 2); JSG (Culture Media, Non-Selective And Non-Differential, 1).
Next steps
- See all 9 Culture Kits, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSI, Culture Kits, 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.