Dilab, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Dilab, Inc.” (first 1985, latest 1987), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 110 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 |
|---|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (10)
- Microbiology (1)
Most recent Dilab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862530 | RAPID AS LATEX | GTQ | 1987-04-21 | 293 |
| K850931 | ALBUMIN | CIX | 1985-06-26 | 111 |
| K850938 | CHOLESTEROL | CGO | 1985-06-25 | 110 |
| K850936 | TOTAL PROTEINS | CEK | 1985-06-25 | 110 |
| K850934 | PHOSPHORUS | CEO | 1985-06-25 | 110 |
| K850933 | URIC ACID | CDH | 1985-06-25 | 110 |
| K850932 | CREATININE | CGX | 1985-06-25 | 110 |
| K850937 | UREA | CDW | 1985-06-10 | 95 |
| K850935 | CHLORIDE | CHJ | 1985-06-10 | 95 |
| K850930 | GLUCOSE | CGE | 1985-06-10 | 95 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dilab, 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 Dilab, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Dilab, Inc.” (first 1985, latest 1987), across 11 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 Dilab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dilab, Inc. is 110 days.
Which FDA product codes appear under Dilab, Inc.?
The most frequent FDA product codes under this applicant name are CDH (Acid, Uric, Phosphotungstate Reduction, 1); CDW (Diacetyl-Monoxime, Urea Nitrogen, 1); CEK (Biuret (Colorimetric), Total Protein, 1).
Next steps
- See all 11 Dilab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDH, Dilab, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.