Pro-Lab Diagnostics: FDA clearances and approvals
Pro-Lab Diagnostics has 5 FDA 510(k) clearances (first 1992, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time: 119 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | 4 | 4 |
| GMZ | Antigens, All Types, Escherichia Coli | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Pro-Lab Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944421 | E.COLI 0157 LATEX TEST | GMZ | 1994-12-15 | 119 |
| K924331 | TRANSYSTEM LIQUID STUART MEDIUM | LIO | 1992-12-24 | 119 |
| K924330 | TRANSYSTEM AMIES WITH CHARCOAL | LIO | 1992-12-24 | 119 |
| K924329 | TRANSYSTEM AMIES W/O CHARCOAL | LIO | 1992-12-24 | 119 |
| K924328 | TRANSYSTEM LIQUID AMIES MEDIUM | LIO | 1992-12-24 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Pro-Lab Diagnostics.
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 Pro-Lab Diagnostics have?
Pro-Lab Diagnostics has 5 FDA 510(k) clearances (first 1992, latest 1994), across 2 product codes in 1 review panel.
How long does FDA take to clear Pro-Lab Diagnostics's 510(k)s?
The median time from FDA receipt to decision across Pro-Lab Diagnostics's cleared 510(k)s is 119 days.
What devices does Pro-Lab Diagnostics make?
Its most frequent FDA product codes are LIO (Device, Specimen Collection, 4); GMZ (Antigens, All Types, Escherichia Coli, 1).
Has Pro-Lab Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching Pro-Lab Diagnostics. Related entities may recall under other names.
Next steps
- See all 5 Pro-Lab Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code LIO, Pro-Lab Diagnostics'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.