Livonia Diagnostics, Inc.
Mchenry, IL, US
Livonia Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Livonia Diagnostics, Inc. between 1984 and 1985. The busiest year on record is 1984, with 15. The most recent is 1985, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 15 |
| 1985 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K852161 | SERUM IRON/VIBC REAGENT SET | JIY | Substantially Equivalent | |
| K844322 | SGOT REAGENT SET | CIQ | Substantially Equivalent | |
| K844283 | SGPT REAGENT SET | CKD | Substantially Equivalent | |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | CIO | Substantially Equivalent | |
| K844156 | UREA NITROGEN REAGENT SET | CDW | Substantially Equivalent | |
| K844182 | INORGANIC PHOSPHORUS REAGENT SET | CEO | Substantially Equivalent | |
| K843894 | HDL PRECIPATATING REAGENT SET | LBR | Substantially Equivalent | |
| K844075 | URIC ACID REAGENT SET | LFQ | Substantially Equivalent | |
| K844024 | CREATININE REAGENT SET | CGX | Substantially Equivalent | |
| K843895 | TOTAL CALCIUM REAGENT SET | CIC | Substantially Equivalent | |
| K843893 | MAGNESIUM REAGENT SET | JGJ | Substantially Equivalent | |
| K843831 | ALBUMIN REAGENT SET | CIX | Substantially Equivalent | |
| K843701 | TOTAL PROTEIN REAGENT SET | CEK | Substantially Equivalent | |
| K843528 | GLUCOSE OXIDASE ENZYMATIC REAGENT SET | CGA | Substantially Equivalent | |
| K843222 | ENZYMATIC CHOLESTEROL KIT | CHH | Substantially Equivalent | |
| K842368 | SICKLE CELL REAGENT SET | GHM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LFQAcid, Uric, Acid Reduction Of Ferric Ion
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CICCresolphthalein Complexone, Calcium
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CIQDiazo, Ast/Sgot
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- LBRLdl & Vldl Precipitation, Hdl
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- GHMTest, Sickle Cell
- 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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Livonia Diagnostics, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Livonia Diagnostics, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain