Gilford Diagnostics
Mchenry, IL, US
Gilford Diagnostics appears in FDA device records in Mchenry, IL. FDA records list 50 510(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
- 50
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 50 510(k) clearances for Gilford Diagnostics between 1978 and 1983. The busiest year on record is 1980, with 16. The most recent is 1983, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 4 |
| 1979 | 10 |
| 1980 | 16 |
| 1981 | 9 |
| 1982 | 7 |
| 1983 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K832094 | BILIRUBIN CALIBRATORS & CONTROL | JIT | Substantially Equivalent | |
| K831844 | DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K831843 | GILCHEM TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K823709 | TRIGLYCERIDE REAGENT (UV) | CDT | Substantially Equivalent | |
| K822739 | AHBD | JMK | Substantially Equivalent | |
| K822334 | BILIRUBIN CALIBRATORS | JIT | Substantially Equivalent | |
| K822289 | CO2/CI STANDARDS | JIX | Substantially Equivalent | |
| K822149 | GILCHEM Y-GT REAGENT | JPZ | Substantially Equivalent | |
| K821719 | AMMONIA REAGENT | JIF | Substantially Equivalent | |
| K820976 | GIL CHEM MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K820975 | GILCHEM ACID PHOSPHATASE REAGENT | CKB | Substantially Equivalent | |
| K813478 | TRIGLYCERIDE CALIBRATORS | JIS | Substantially Equivalent | |
| K812912 | GILCHEM ALP REAGENT | CJE | Substantially Equivalent | |
| K812861 | CHOLESTEROL CALIBRATORS | JIS | Substantially Equivalent | |
| K812110 | GILCHEM CALCIUM REAGENT | CIC | Substantially Equivalent | |
| K812109 | GILCHEM CREATININE REAGENT | CGX | Substantially Equivalent | |
| K811886 | CESIUM DILUENT 7.5M | JGT | Substantially Equivalent | |
| K811659 | CREATININE REAGENT | CGX | Substantially Equivalent | |
| K810405 | CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K803301 | CREATINE KINASE REAGENT | CGS | Substantially Equivalent | |
| K802633 | BUN/GLUCOSE STANDARDS | JIX | Substantially Equivalent | |
| K802632 | ALBUMIN/TOTAL PROTEIN STANDARDS | JIX | Substantially Equivalent | |
| K802631 | CREATININE STANDARDS | JIS | Substantially Equivalent | |
| K801600 | GLUCOSE (TRINDER) REAGENT | CGA | Substantially Equivalent | |
| K801012 | TRIGLYCERIDE REAGENT (COLOR) | JGY | Substantially Equivalent | |
| K800996 | HDL REAGENT | LBR | Substantially Equivalent | |
| K800341 | BUN REAGENT | CDQ | Substantially Equivalent | |
| K800120 | LDH (L-P) REAGENT | CFJ | Substantially Equivalent | |
| K800065 | ASI REAGENT | CIT | Substantially Equivalent | |
| K800043 | CESIUM DILUENT (1.5 MM/L) | JIX | Substantially Equivalent | |
| K800042 | LITHIUM STANDARD (1MM/L) | JIS | Substantially Equivalent | |
| K800041 | SODIUM/POTASSIUM 140/5 MEQ/L) | JIX | Substantially Equivalent | |
| K800040 | SODIUM/POTASSIUM (100/100 MEQ/E) | JIX | Substantially Equivalent | |
| K800039 | LITHIUM DILUENT (1500 MM/E) | JIH | Substantially Equivalent | |
| K800038 | ALT REAGENT | CKA | Substantially Equivalent | |
| K792605 | CHLORIDE REAGENT | CHJ | Substantially Equivalent | |
| K792046 | URIC ACID STANDARD | JIS | Substantially Equivalent | |
| K791874 | CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD | JIX | Substantially Equivalent | |
| K791725 | CHOLINESTERASE REAGENT | DIH | Substantially Equivalent | |
| K791754 | URIC ACID REAGENT | KNK | Substantially Equivalent | |
| K791708 | INORGANIC PHOSPHORUS REAGENT | CEO | Substantially Equivalent | |
| K791213 | GLUCOSE (GDH) REAGENT | LFR | Substantially Equivalent | |
| K790786 | GLUCOSE (HK) REAGENT | CFR | Substantially Equivalent | |
| K790771 | LD-P REAGENT (LDH P-L REAGENT) | CFJ | Substantially Equivalent | |
| K781782 | BUN | CDQ | Substantially Equivalent | |
| K781784 | AST | CIT | Substantially Equivalent | |
| K781783 | BLOOD SUGAR | LFR | Substantially Equivalent | |
| K781775 | LDH | CFJ | Substantially Equivalent | |
| K781774 | TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K781773 | ALBUMIN REAGENT | CIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- JGYColorimetric Method, Triglycerides
- DIHColorimetry, Cholinesterase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JIFEnzymatic Method, Ammonia
- JIHFlame Photometry, Lithium
- JGTFlame Photometry, Sodium
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain