Company ยท US
Omega Medical Electronics
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1983. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHD | Acid, Ferric Ion-Sulfuric, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIQ | Diazo, Ast/Sgot | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 |
| GKK | Cyanomethemoglobin | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 1983 | K823691 | PHOSPHORUS REAGENT SET Omega Medical Electronics | CEO |
| Jul 22, 1982 | K821212 | UREA NITROGEN REAGENT SET Omega Medical Electronics | CDW |
| Jul 22, 1982 | K821206 | SGPT-UV REAGENT SET Omega Medical Electronics | CKA |
| Jul 22, 1982 | K821204 | GLUCOSE(ENZYMATIC) REAGENT SET Omega Medical Electronics | CGA |
| Jul 20, 1982 | K821208 | SGOT-UV REAGENT SET Omega Medical Electronics | CIT |
| Jul 20, 1982 | K821205 | TRIGLYCERIDE REAGENT SET Omega Medical Electronics | CDT |
| Jul 20, 1982 | K821201 | LDH-UV REAGENT SET Omega Medical Electronics | CFJ |
| Jul 14, 1982 | K821209 | SGOT REAGENT SET Omega Medical Electronics | CIQ |
| Jul 14, 1982 | K821207 | SGPT REAGENT SET Omega Medical Electronics | CKD |
| Jul 13, 1982 | K821213 | URIC ACID REAGENT SET Omega Medical Electronics | CDH |
| Jul 13, 1982 | K821210 | SERUM TOTAL PROTEIN REAGENT SET Omega Medical Electronics | CEK |
| Jul 13, 1982 | K821203 | HDL PRECIPITANT REAGENT SET Omega Medical Electronics | LBR |
| Jul 13, 1982 | K821200 | ALKALINE PHOSPHOTASE REAGENT SET Omega Medical Electronics | CIO |
| Jul 13, 1982 | K821199 | CREATININE REAGENT SET Omega Medical Electronics | CGX |
| Jul 13, 1982 | K821198 | DIRECT GLUCOSE REAGENT SET Omega Medical Electronics | CGE |
| Jul 13, 1982 | K821197 | TOTAL BILIRUBIN REAGENT SET Omega Medical Electronics | CIG |
| Jul 13, 1982 | K821196 | SERUM CALCIUM REAGENT SET Omega Medical Electronics | CIC |
| Jul 13, 1982 | K821195 | CHOLESTEROL REAGENT SET Omega Medical Electronics | CHD |
| Jul 13, 1982 | K821193 | ALBUMIN REAGENT SET Omega Medical Electronics | CIX |
| May 24, 1982 | K821202 | HEMOGLOBIN REAGENT SET Omega Medical Electronics | GKK |
| May 21, 1982 | K821214 | URIC ACID REAGENT SET(ENZYMATIC Omega Medical Electronics | KNK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||