Company ยท US
United Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1989. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 2 |
| CGC | Radioimmunoassay, Gastrin | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| JIS | Calibrator, Primary | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 1989 | K884977 | GAS TRAK PLUS United Diagnostics, Inc. | JJY |
| Aug 4, 1986 | K862278 | GAS-TRAK United Diagnostics, Inc. | JJY |
| Nov 27, 1984 | K844018 | GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 United Diagnostics, Inc. | JJY |
| Nov 27, 1984 | K843986 | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 United Diagnostics, Inc. | JJY |
| Aug 10, 1983 | K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL United Diagnostics, Inc. | JJR |
| Jul 28, 1983 | K831814 | CALIBRATION STANDARD-HEMOGLOBIN United Diagnostics, Inc. | KRZ |
| Jul 28, 1983 | K831813 | CO-OXIMETER CONTROL United Diagnostics, Inc. | KHG |
| Jun 22, 1983 | K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- United Diagnostics, Inc. | CGC |
| Apr 1, 1982 | K820705 | GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL United Diagnostics, Inc. | JJS |
| Dec 31, 1981 | K813517 | BLOOD GAS ANALYSIS, STANDARDS CONTROLS United Diagnostics, Inc. | CHL |
| Mar 31, 1981 | K810618 | AMPULED FLAME PHOTOMETER STANDARDS United Diagnostics, Inc. | JIS |
| Nov 13, 1979 | K792098 | GAS-TRAK BLOOD GAS CONTROL United Diagnostics, Inc. | JJS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||