United Diagnostics, Inc.
Medical device manufacturer in Natick, MA.
12510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 4
- JJS Controls For Blood-Gases, (Assayed And… 2
- JIS Calibrator, Primary 1
- CHL Electrode Measurement, Blood-Gases (Pco2… 1
- CGC Radioimmunoassay, Gastrin 1
- KHG Whole Blood Hemoglobin Determination 1
- KRZ Calibrator For Hemoglobin And Hematocrit… 1
- JJR Electrolyte Controls (Assayed And Unassayed) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K884977 | Gas Trak PlusJJY · Traditional | 01/27/1989SE |
| K862278 | Gas-TrakJJY · Traditional | 08/04/1986SE |
| K844018 | Gas Trak Brand Co-Oximeter Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K843986 | Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K831389 | Stat-Trak Liquid Electrolyte ControlJJR · Traditional | 08/10/1983SE |
| K831814 | Calibration Standard-HemoglobinKRZ · Traditional | 07/28/1983SE |
| K831813 | Co-Oximeter ControlKHG · Traditional | 07/28/1983SE |
| K831075 | Blood Gas & Flame Photometer Instru-CGC · Traditional | 06/22/1983SE |
| K820705 | Gas-Trak 2 Synthetic Blood Gas ControlJJS · Traditional | 04/01/1982SE |
| K813517 | Blood Gas Analysis, Standards ControlsCHL · Traditional | 12/31/1981SE |
| K810618 | Ampuled Flame Photometer StandardsJIS · Traditional | 03/31/1981SE |
| K792098 | Gas-Trak Blood Gas ControlJJS · Traditional | 11/13/1979SE |