Applied Polytechnology, Inc.: FDA clearances and approvals
Applied Polytechnology, Inc. has 7 FDA 510(k) clearances (first 1984, latest 1986), across 5 product codes in 2 review panels. Median 510(k) review time: 53 days.
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 |
|---|---|---|---|
| JXA | Kit, Screening, Urine | 3 | 3 |
| JTA | Monitor, Microbial Growth | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
| JTW | System, Transport, Aerobic | 1 | 1 |
| LLG | Kit, Igg, Platelet Associated | 1 | 1 |
Review panels
- Microbiology (6)
- Hematology (1)
Most recent Applied Polytechnology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860483 | FILTRA-CHECK-UTI | JXA | 1986-04-04 | 53 |
| K843834 | BACTERIURIA DETECT. DEVICE APTEK II | JXA | 1984-11-29 | 59 |
| K843833 | BACTERIURIA DETECT DEVICE, MULTI SAMPLER | JXA | 1984-11-29 | 59 |
| K843359 | URINE TRANSPORT KIT | JTW | 1984-09-27 | 31 |
| K843316 | INDOLE SPOT TEST KIT 270-25 | JTO | 1984-09-11 | 18 |
| K840257 | RAPID IMMUNO-ASSAY SYS | LLG | 1984-04-19 | 87 |
| K834264 | REVERSE-FLOW SYSTEM | JTA | 1984-01-13 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Applied Polytechnology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Applied Polytechnology, Inc. have?
Applied Polytechnology, Inc. has 7 FDA 510(k) clearances (first 1984, latest 1986), across 5 product codes in 2 review panels.
How long does FDA take to clear Applied Polytechnology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Applied Polytechnology, Inc.'s cleared 510(k)s is 53 days.
What devices does Applied Polytechnology, Inc. make?
Its most frequent FDA product codes are JXA (Kit, Screening, Urine, 3); JTA (Monitor, Microbial Growth, 1); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 1).
Has Applied Polytechnology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Applied Polytechnology, Inc. Related entities may recall under other names.
Next steps
- See all 7 Applied Polytechnology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JXA, Applied Polytechnology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.