Medilab Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medilab Corp.” (first 1983, latest 1984), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (1)
- Immunology (1)
- Microbiology (1)
Most recent Medilab Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841863 | MONO-TEC | KTN | 1984-06-13 | 40 |
| K841862 | IMMU-TEC | DCK | 1984-06-13 | 40 |
| K840291 | MCS ALBUMIN REAGENT | CIX | 1984-03-30 | 66 |
| K840290 | MCS TOTAL PROTEIN REAGENT | CEK | 1984-03-30 | 66 |
| K840289 | LYSE-TEC | GGK | 1984-03-05 | 41 |
| K832918 | PREGNA-TEC | JHJ | 1983-11-03 | 70 |
| K832527 | PREGNA-TEC | JHJ | 1983-09-12 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Medilab Corp..
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.
- Medilab Manutencao E Sitemas Ltda (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medilab Corp.?
FDA lists 7 510(k) clearances under the applicant name “Medilab Corp.” (first 1983, latest 1984), across 6 product codes in 4 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 Medilab Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medilab Corp. is 45 days.
Which FDA product codes appear under Medilab Corp.?
The most frequent FDA product codes under this applicant name are JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2); CEK (Biuret (Colorimetric), Total Protein, 1); CIX (Bromcresol Green Dye-Binding, Albumin, 1).
Next steps
- See all 7 Medilab Corp. clearances with predicates and recalls
- Run predicate analysis for product code JHJ, Medilab Corp.'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.