Dimension Diagnostics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Dimension Diagnostics” (first 1985, latest 1987), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
Most recent Dimension Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863223 | DIMENSION-WBG | CGA | 1987-03-10 | 201 |
| K861366 | ALT-30, 60 AND 100 | CKA | 1986-06-25 | 75 |
| K854967 | CRITIC - SF, ASSAYED | JJY | 1986-01-07 | 27 |
| K853943 | CRITIC C LEVEL I & II | JJY | 1985-12-23 | 90 |
| K852295 | UROL-GUANT | JJW | 1985-07-22 | 54 |
| K844848 | IMA-TROL IMMUNOASSAY CONTROL | JJY | 1985-03-01 | 78 |
| K844760 | UROL-QUAL | JJY | 1985-01-08 | 32 |
| K844709 | CRITIC-ARS | JIX | 1985-01-08 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Dimension Diagnostics.
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.
- Dimension Inx Corp. (1 510(k)s)
- Dimension Specialty Co., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dimension Diagnostics?
FDA lists 8 510(k) clearances under the applicant name “Dimension Diagnostics” (first 1985, latest 1987), across 5 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 Dimension Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dimension Diagnostics is 64 days.
Which FDA product codes appear under Dimension Diagnostics?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); CGA (Glucose Oxidase, Glucose, 1); CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt, 1).
Next steps
- See all 8 Dimension Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JJY, Dimension Diagnostics'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.