Company ยท US
Livonia Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1985. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIQ | Diazo, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 |
| GHM | Test, Sickle Cell | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 1985 | K852161 | SERUM IRON/VIBC REAGENT SET Livonia Diagnostics, Inc. | JIY |
| Nov 27, 1984 | K844322 | SGOT REAGENT SET Livonia Diagnostics, Inc. | CIQ |
| Nov 27, 1984 | K844283 | SGPT REAGENT SET Livonia Diagnostics, Inc. | CKD |
| Nov 20, 1984 | K844237 | ALKALINE PHOSPHATASE REAGENT SET Livonia Diagnostics, Inc. | CIO |
| Nov 13, 1984 | K844156 | UREA NITROGEN REAGENT SET Livonia Diagnostics, Inc. | CDW |
| Nov 9, 1984 | K844182 | INORGANIC PHOSPHORUS REAGENT SET Livonia Diagnostics, Inc. | CEO |
| Nov 2, 1984 | K843894 | HDL PRECIPATATING REAGENT SET Livonia Diagnostics, Inc. | LBR |
| Oct 30, 1984 | K844075 | URIC ACID REAGENT SET Livonia Diagnostics, Inc. | LFQ |
| Oct 30, 1984 | K844024 | CREATININE REAGENT SET Livonia Diagnostics, Inc. | CGX |
| Oct 30, 1984 | K843895 | TOTAL CALCIUM REAGENT SET Livonia Diagnostics, Inc. | CIC |
| Oct 30, 1984 | K843893 | MAGNESIUM REAGENT SET Livonia Diagnostics, Inc. | JGJ |
| Oct 11, 1984 | K843831 | ALBUMIN REAGENT SET Livonia Diagnostics, Inc. | CIX |
| Oct 1, 1984 | K843701 | TOTAL PROTEIN REAGENT SET Livonia Diagnostics, Inc. | CEK |
| Sep 28, 1984 | K843528 | GLUCOSE OXIDASE ENZYMATIC REAGENT SET Livonia Diagnostics, Inc. | CGA |
| Sep 28, 1984 | K843222 | ENZYMATIC CHOLESTEROL KIT Livonia Diagnostics, Inc. | CHH |
| Jul 20, 1984 | K842368 | SICKLE CELL REAGENT SET Livonia Diagnostics, Inc. | GHM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||