Omega Medical Electronics
Mchenry, IL, US
Omega Medical Electronics appears in FDA device records in Mchenry, IL. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Omega Medical Electronics between 1982 and 1983. The busiest year on record is 1982, with 20. The most recent is 1983, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 20 |
| 1983 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K823691 | PHOSPHORUS REAGENT SET | CEO | Substantially Equivalent | |
| K821212 | UREA NITROGEN REAGENT SET | CDW | Substantially Equivalent | |
| K821206 | SGPT-UV REAGENT SET | CKA | Substantially Equivalent | |
| K821204 | GLUCOSE(ENZYMATIC) REAGENT SET | CGA | Substantially Equivalent | |
| K821208 | SGOT-UV REAGENT SET | CIT | Substantially Equivalent | |
| K821205 | TRIGLYCERIDE REAGENT SET | CDT | Substantially Equivalent | |
| K821201 | LDH-UV REAGENT SET | CFJ | Substantially Equivalent | |
| K821209 | SGOT REAGENT SET | CIQ | Substantially Equivalent | |
| K821207 | SGPT REAGENT SET | CKD | Substantially Equivalent | |
| K821213 | URIC ACID REAGENT SET | CDH | Substantially Equivalent | |
| K821210 | SERUM TOTAL PROTEIN REAGENT SET | CEK | Substantially Equivalent | |
| K821203 | HDL PRECIPITANT REAGENT SET | LBR | Substantially Equivalent | |
| K821200 | ALKALINE PHOSPHOTASE REAGENT SET | CIO | Substantially Equivalent | |
| K821199 | CREATININE REAGENT SET | CGX | Substantially Equivalent | |
| K821198 | DIRECT GLUCOSE REAGENT SET | CGE | Substantially Equivalent | |
| K821197 | TOTAL BILIRUBIN REAGENT SET | CIG | Substantially Equivalent | |
| K821196 | SERUM CALCIUM REAGENT SET | CIC | Substantially Equivalent | |
| K821195 | CHOLESTEROL REAGENT SET | CHD | Substantially Equivalent | |
| K821193 | ALBUMIN REAGENT SET | CIX | Substantially Equivalent | |
| K821202 | HEMOGLOBIN REAGENT SET | GKK | Substantially Equivalent | |
| K821214 | URIC ACID REAGENT SET(ENZYMATIC | KNK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol
- CDHAcid, Uric, Phosphotungstate Reduction
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CICCresolphthalein Complexone, Calcium
- GKKCyanomethemoglobin
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CIGDiazo Colorimetry, Bilirubin
- CIQDiazo, Ast/Sgot
- CGAGlucose Oxidase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CGEOrthotoluidine, Glucose
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain