Applied BioCode, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Applied BioCode, Inc.” (first 2018, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 109 days. Since 2017 the median was 109 days, against 94 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 266 |
| 2019 | 2 | 98 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 109 |
| 2026 | 1 | 130 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Applied BioCode, Inc. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 3 | 3 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | 2 |
Review panels
- Microbiology (5)
Most recent Applied BioCode, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | OCC | 2026-05-01 | 130 |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | 2025-01-10 | 109 |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | OCC | 2019-12-23 | 104 |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | PCH | 2019-06-05 | 91 |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | 2018-09-28 | 266 |
Recalls
openFDA lists no recalls under a recalling firm named Applied BioCode, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Spectral Imaging , Ltd. (8 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied BioCode, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Applied BioCode, Inc.” (first 2018, latest 2026), across 2 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 Applied BioCode, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied BioCode, Inc. is 109 days. Since 2017: 109 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Applied BioCode, Inc.?
The most frequent FDA product codes under this applicant name are PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, 3); OCC (Respiratory Virus Panel Nucleic Acid Assay System, 2).
Next steps
- See all 5 Applied BioCode, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PCH, Applied BioCode, 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.