United Diagnostics, Inc.
Mchenry, IL, US
United Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for United Diagnostics, Inc. between 1979 and 1989. The busiest year on record is 1983, with 4. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 2 |
| 1986 | 1 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K884977 | GAS TRAK PLUS | JJY | Substantially Equivalent | |
| K862278 | GAS-TRAK | JJY | Substantially Equivalent | |
| K844018 | GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 | JJY | Substantially Equivalent | |
| K843986 | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 | JJY | Substantially Equivalent | |
| K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL | JJR | Substantially Equivalent | |
| K831814 | CALIBRATION STANDARD-HEMOGLOBIN | KRZ | Substantially Equivalent | |
| K831813 | CO-OXIMETER CONTROL | KHG | Substantially Equivalent | |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | CGC | Substantially Equivalent | |
| K820705 | GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL | JJS | Substantially Equivalent | |
| K813517 | BLOOD GAS ANALYSIS, STANDARDS CONTROLS | CHL | Substantially Equivalent | |
| K810618 | AMPULED FLAME PHOTOMETER STANDARDS | JIS | Substantially Equivalent | |
| K792098 | GAS-TRAK BLOOD GAS CONTROL | JJS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JISCalibrator, Primary
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JJRElectrolyte Controls (Assayed And Unassayed)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGCRadioimmunoassay, Gastrin
- KHGWhole Blood Hemoglobin Determination
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain