Protos Laboratories: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Protos Laboratories” (first 1979, latest 1980), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 47 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 |
|---|---|---|---|
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DEH | Lambda, Antigen, Antiserum, Control | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
Review panels
- Immunology (6)
Most recent Protos Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802257 | GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC | DEW | 1980-10-31 | 45 |
| K802196 | GOAT ANTI-HUMAN COMPLEMENT C4 | DBI | 1980-10-31 | 51 |
| K802177 | GOAT ANTI-HUMAN IGM | DFT | 1980-10-31 | 52 |
| K791560 | GOAT ANTI-HUMAN C-REACTIVE PROTEIN | DCK | 1979-09-24 | 38 |
| K791605 | GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN | DEM | 1979-09-04 | 15 |
| K791115 | GOAR ANTI-HUMAN LAMBODA CHAIN | DEH | 1979-08-03 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Protos Laboratories.
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 Protos Laboratories?
FDA lists 6 510(k) clearances under the applicant name “Protos Laboratories” (first 1979, latest 1980), across 6 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 Protos Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Protos Laboratories is 47 days.
Which FDA product codes appear under Protos Laboratories?
The most frequent FDA product codes under this applicant name are DBI (Complement C4, Antigen, Antiserum, Control, 1); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 1); DEH (Lambda, Antigen, Antiserum, Control, 1).
Next steps
- See all 6 Protos Laboratories clearances with predicates and recalls
- Run predicate analysis for product code DBI, Protos Laboratories'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.