Anarobe Systems: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Anarobe Systems” (first 1984, latest 1984), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | 2 | 2 |
| JSF | Culture Media, Single Biochemical Test | 2 | 2 |
| JSH | Culture Media, Non-Selective And Differential | 2 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (7)
Most recent Anarobe Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842854 | MUELLER HINTON BROTH | JTZ | 1984-08-17 | 28 |
| K842850 | TRIPLE SUGAR IRON | JSH | 1984-08-17 | 28 |
| K842851 | ORNITHINE INDOLE MOTILITY | JSH | 1984-08-07 | 18 |
| K842855 | CHRISTENSEN'S UREA AGAR | JSF | 1984-08-03 | 14 |
| K842853 | LYSINE IRON AGAR | JSF | 1984-08-03 | 14 |
| K842852 | BRAIN HEART INFUSION BROTH | JSC | 1984-08-03 | 14 |
| K842849 | TRYPTICASE SOY BROTH | JSC | 1984-08-03 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Anarobe Systems.
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 Anarobe Systems?
FDA lists 7 510(k) clearances under the applicant name “Anarobe Systems” (first 1984, latest 1984), across 4 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 Anarobe Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anarobe Systems is 14 days.
Which FDA product codes appear under Anarobe Systems?
The most frequent FDA product codes under this applicant name are JSC (Culture Media, General Nutrient Broth, 2); JSF (Culture Media, Single Biochemical Test, 2); JSH (Culture Media, Non-Selective And Differential, 2).
Next steps
- See all 7 Anarobe Systems clearances with predicates and recalls
- Run predicate analysis for product code JSC, Anarobe Systems'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.