Omega Medical Electronics
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K823691 | PHOSPHORUS REAGENT SET | January 7, 1983 |
| K821206 | SGPT-UV REAGENT SET | July 22, 1982 |
| K821212 | UREA NITROGEN REAGENT SET | July 22, 1982 |
| K821204 | GLUCOSE(ENZYMATIC) REAGENT SET | July 22, 1982 |
| K821208 | SGOT-UV REAGENT SET | July 20, 1982 |
| K821201 | LDH-UV REAGENT SET | July 20, 1982 |
| K821205 | TRIGLYCERIDE REAGENT SET | July 20, 1982 |
| K821207 | SGPT REAGENT SET | July 14, 1982 |
| K821209 | SGOT REAGENT SET | July 14, 1982 |
| K821193 | ALBUMIN REAGENT SET | July 13, 1982 |
| K821198 | DIRECT GLUCOSE REAGENT SET | July 13, 1982 |
| K821199 | CREATININE REAGENT SET | July 13, 1982 |
| K821203 | HDL PRECIPITANT REAGENT SET | July 13, 1982 |
| K821197 | TOTAL BILIRUBIN REAGENT SET | July 13, 1982 |
| K821196 | SERUM CALCIUM REAGENT SET | July 13, 1982 |
| K821200 | ALKALINE PHOSPHOTASE REAGENT SET | July 13, 1982 |
| K821213 | URIC ACID REAGENT SET | July 13, 1982 |
| K821210 | SERUM TOTAL PROTEIN REAGENT SET | July 13, 1982 |
| K821195 | CHOLESTEROL REAGENT SET | July 13, 1982 |
| K821202 | HEMOGLOBIN REAGENT SET | May 24, 1982 |