Trend Scientific, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Trend Scientific, Inc.” (first 1983, latest 1996), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 132 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 |
|---|---|---|---|
| MHI | Giardia Spp. | 2 | 2 |
| JTR | Kit, Quality Control For Culture Media | 1 | 1 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| MHJ | Cryptosporidium Spp. | 1 | 1 |
Review panels
- Microbiology (5)
- Clinical Chemistry (1)
Most recent Trend Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | KHW | 1996-08-08 | 281 |
| K955755 | TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS | MHJ | 1996-07-11 | 204 |
| K952467 | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) | MHI | 1995-11-20 | 178 |
| K953284 | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM | MHI | 1995-10-06 | 85 |
| K862914 | FEKAL CHECK PARASITOLOGY CONTROL SLIDE | JTR | 1986-09-16 | 46 |
| K830769 | FEKAL CON-TRATE SYSTEM | KLI | 1983-04-05 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Trend Scientific, 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.
- Trend Medical, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trend Scientific, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Trend Scientific, Inc.” (first 1983, latest 1996), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trend Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trend Scientific, Inc. is 132 days.
Which FDA product codes appear under Trend Scientific, Inc.?
The most frequent FDA product codes under this applicant name are MHI (Giardia Spp., 2); JTR (Kit, Quality Control For Culture Media, 1); KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp., 1).
Next steps
- See all 6 Trend Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MHI, Trend Scientific, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.