Turpen Laboratory Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Turpen Laboratory Systems, Inc.” (first 1983, latest 1987), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 | 3 |
| GIF | Diluent, Blood Cell | 1 | 1 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 1 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (2)
Most recent Turpen Laboratory Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870836 | ATAC 1500 CHEMISTRY ANALYZER | JJE | 1987-04-01 | 29 |
| K863332 | ATAC 4300 HEMATOLOGY CELL COUNTER | GKL | 1986-09-29 | 33 |
| K851321 | ATAC 2000 CHEMISTRY ANALYZER | JQP | 1985-04-25 | 23 |
| K843059 | ATAC 2000 | JJE | 1984-10-11 | 69 |
| K832115 | ATAC 3000 | JJE | 1984-01-10 | 194 |
| K832116 | ATAC 4700 HEMATOLOGY CELL COUNTER | GIF | 1983-10-20 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Turpen Laboratory Systems, 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 Turpen Laboratory Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Turpen Laboratory Systems, Inc.” (first 1983, latest 1987), across 4 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 Turpen Laboratory Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Turpen Laboratory Systems, Inc. is 51 days.
Which FDA product codes appear under Turpen Laboratory Systems, Inc.?
The most frequent FDA product codes under this applicant name are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 3); GIF (Diluent, Blood Cell, 1); GKL (Counter, Cell, Automated (Particle Counter), 1).
Next steps
- See all 6 Turpen Laboratory Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJE, Turpen Laboratory Systems, 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.