Applications Lab: FDA clearances and approvals
Applications Lab has 10 FDA 510(k) clearances (first 1985, latest 1985), across 10 product codes in 1 review panel. Median 510(k) review time: 19 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 |
|---|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
Review panels
- Immunology (10)
Most recent Applications Lab 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN | DEM | 1985-03-14 | 29 |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | DAO | 1985-03-14 | 29 |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | DEB | 1985-03-05 | 18 |
| K850589 | SPQ TEST SYSTEM FOR TRANSFERRIN | DDG | 1985-03-05 | 20 |
| K850588 | SPQ TEST SYSTEM FOR COMPLEMENT C3 | CZW | 1985-03-05 | 20 |
| K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN | DAD | 1985-03-05 | 20 |
| K850590 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | DCK | 1985-03-01 | 16 |
| K850585 | SPQ TEST SYSTEM FOR COMPLEMENT C4 | DBI | 1985-03-01 | 16 |
| K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G | DEW | 1985-03-01 | 16 |
| K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A | CZP | 1985-03-01 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Applications Lab.
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 Applications Lab have?
Applications Lab has 10 FDA 510(k) clearances (first 1985, latest 1985), across 10 product codes in 1 review panel.
How long does FDA take to clear Applications Lab's 510(k)s?
The median time from FDA receipt to decision across Applications Lab's cleared 510(k)s is 19 days.
What devices does Applications Lab make?
Its most frequent FDA product codes are CZP (Iga, Antigen, Antiserum, Control, 1); CZW (Complement C3, Antigen, Antiserum, Control, 1); DAD (Haptoglobin, Antigen, Antiserum, Control, 1).
Has Applications Lab had device recalls?
openFDA lists no recalls under a recalling firm name matching Applications Lab. Related entities may recall under other names.
Next steps
- See all 10 Applications Lab clearances with predicates and recalls
- Run predicate analysis for product code CZP, Applications Lab'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.