Company ยท US
Gilford Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1983. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 7 |
| JIS | Calibrator, Primary | 5 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 |
| JIT | Calibrator, Secondary | 2 |
| LFR | Glucose Dehydrogenase, Glucose | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 1983 | K832094 | BILIRUBIN CALIBRATORS & CONTROL Gilford Diagnostics | JIT |
| Jul 18, 1983 | K831844 | DIRECT BILIRUBIN REAGENT Gilford Diagnostics | CIG |
| Jul 18, 1983 | K831843 | GILCHEM TOTAL BILIRUBIN REAGENT Gilford Diagnostics | CIG |
| Jan 7, 1983 | K823709 | TRIGLYCERIDE REAGENT (UV) Gilford Diagnostics | CDT |
| Oct 18, 1982 | K822739 | AHBD Gilford Diagnostics | JMK |
| Sep 2, 1982 | K822334 | BILIRUBIN CALIBRATORS Gilford Diagnostics | JIT |
| Aug 24, 1982 | K822289 | CO2/CI STANDARDS Gilford Diagnostics | JIX |
| Aug 12, 1982 | K822149 | GILCHEM Y-GT REAGENT Gilford Diagnostics | JPZ |
| Jun 24, 1982 | K821719 | AMMONIA REAGENT Gilford Diagnostics | JIF |
| Apr 26, 1982 | K820976 | GIL CHEM MAGNESIUM REAGENT Gilford Diagnostics | JGJ |
| Apr 26, 1982 | K820975 | GILCHEM ACID PHOSPHATASE REAGENT Gilford Diagnostics | CKB |
| Dec 22, 1981 | K813478 | TRIGLYCERIDE CALIBRATORS Gilford Diagnostics | JIS |
| Nov 2, 1981 | K812912 | GILCHEM ALP REAGENT Gilford Diagnostics | CJE |
| Oct 23, 1981 | K812861 | CHOLESTEROL CALIBRATORS Gilford Diagnostics | JIS |
| Aug 13, 1981 | K812110 | GILCHEM CALCIUM REAGENT Gilford Diagnostics | CIC |
| Aug 13, 1981 | K812109 | GILCHEM CREATININE REAGENT Gilford Diagnostics | CGX |
| Jul 23, 1981 | K811886 | CESIUM DILUENT 7.5M Gilford Diagnostics | JGT |
| Jun 26, 1981 | K811659 | CREATININE REAGENT Gilford Diagnostics | CGX |
| Feb 26, 1981 | K810405 | CHOLESTEROL REAGENT Gilford Diagnostics | CHH |
| Jan 16, 1981 | K803301 | CREATINE KINASE REAGENT Gilford Diagnostics | CGS |
| Dec 11, 1980 | K802633 | BUN/GLUCOSE STANDARDS Gilford Diagnostics | JIX |
| Dec 11, 1980 | K802632 | ALBUMIN/TOTAL PROTEIN STANDARDS Gilford Diagnostics | JIX |
| Dec 11, 1980 | K802631 | CREATININE STANDARDS Gilford Diagnostics | JIS |
| Aug 27, 1980 | K801600 | GLUCOSE (TRINDER) REAGENT Gilford Diagnostics | CGA |
| May 14, 1980 | K801012 | TRIGLYCERIDE REAGENT (COLOR) Gilford Diagnostics | JGY |
| May 14, 1980 | K800996 | HDL REAGENT Gilford Diagnostics | LBR |
| Mar 12, 1980 | K800341 | BUN REAGENT Gilford Diagnostics | CDQ |
| Feb 13, 1980 | K800120 | LDH (L-P) REAGENT Gilford Diagnostics | CFJ |
| Feb 5, 1980 | K800065 | ASI REAGENT Gilford Diagnostics | CIT |
| Jan 21, 1980 | K800043 | CESIUM DILUENT (1.5 MM/L) Gilford Diagnostics | JIX |
| Jan 21, 1980 | K800042 | LITHIUM STANDARD (1MM/L) Gilford Diagnostics | JIS |
| Jan 21, 1980 | K800041 | SODIUM/POTASSIUM 140/5 MEQ/L) Gilford Diagnostics | JIX |
| Jan 21, 1980 | K800040 | SODIUM/POTASSIUM (100/100 MEQ/E) Gilford Diagnostics | JIX |
| Jan 21, 1980 | K800039 | LITHIUM DILUENT (1500 MM/E) Gilford Diagnostics | JIH |
| Jan 21, 1980 | K800038 | ALT REAGENT Gilford Diagnostics | CKA |
| Jan 16, 1980 | K792605 | CHLORIDE REAGENT Gilford Diagnostics | CHJ |
| Oct 30, 1979 | K792046 | URIC ACID STANDARD Gilford Diagnostics | JIS |
| Oct 17, 1979 | K791874 | CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD Gilford Diagnostics | JIX |
| Oct 17, 1979 | K791725 | CHOLINESTERASE REAGENT Gilford Diagnostics | DIH |
| Sep 27, 1979 | K791754 | URIC ACID REAGENT Gilford Diagnostics | KNK |
| Sep 24, 1979 | K791708 | INORGANIC PHOSPHORUS REAGENT Gilford Diagnostics | CEO |
| Aug 10, 1979 | K791213 | GLUCOSE (GDH) REAGENT Gilford Diagnostics | LFR |
| Jun 15, 1979 | K790786 | GLUCOSE (HK) REAGENT Gilford Diagnostics | CFR |
| May 15, 1979 | K790771 | LD-P REAGENT (LDH P-L REAGENT) Gilford Diagnostics | CFJ |
| Jan 10, 1979 | K781782 | BUN Gilford Diagnostics | CDQ |
| Jan 3, 1979 | K781784 | AST Gilford Diagnostics | CIT |
| Dec 4, 1978 | K781783 | BLOOD SUGAR Gilford Diagnostics | LFR |
| Nov 22, 1978 | K781775 | LDH Gilford Diagnostics | CFJ |
| Nov 22, 1978 | K781774 | TOTAL PROTEIN Gilford Diagnostics | CEK |
| Nov 22, 1978 | K781773 | ALBUMIN REAGENT Gilford Diagnostics | CIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||