United Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “United Diagnostics, Inc.” (first 1979, latest 1989), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 48 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 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 2 | 2 |
| CGC | Radioimmunoassay, Gastrin | 1 | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 | 1 |
Review panels
- Clinical Chemistry (10)
- Hematology (2)
Most recent United Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884977 | GAS TRAK PLUS | JJY | 1989-01-27 | 58 |
| K862278 | GAS-TRAK | JJY | 1986-08-04 | 49 |
| K844018 | GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 | JJY | 1984-11-27 | 47 |
| K843986 | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 | JJY | 1984-11-27 | 47 |
| K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL | JJR | 1983-08-10 | 103 |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | KRZ | 1983-07-28 | 52 |
| K831813 | CO-OXIMETER CONTROL | KHG | 1983-07-28 | 52 |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | CGC | 1983-06-22 | 79 |
| K820705 | GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL | JJS | 1982-04-01 | 16 |
| K813517 | BLOOD GAS ANALYSIS, STANDARDS CONTROLS | CHL | 1981-12-31 | 15 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named United Diagnostics, 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.
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.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Consortium (15 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Diagnostics, Inc.?
FDA lists 12 510(k) clearances under the applicant name “United Diagnostics, Inc.” (first 1979, latest 1989), across 8 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 United Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Diagnostics, Inc. is 48 days.
Which FDA product codes appear under United Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); JJS (Controls For Blood-Gases, (Assayed And Unassayed), 2); CGC (Radioimmunoassay, Gastrin, 1).
Next steps
- See all 12 United Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, United Diagnostics, 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, 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.