FDA 510(k) Applications Submitted by GILFORD DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K800038 01/07/1980 ALT REAGENT GILFORD DIAGNOSTICS
K800039 01/07/1980 LITHIUM DILUENT (1500 MM/E) GILFORD DIAGNOSTICS
K800040 01/07/1980 SODIUM/POTASSIUM (100/100 MEQ/E) GILFORD DIAGNOSTICS
K800041 01/07/1980 SODIUM/POTASSIUM 140/5 MEQ/L) GILFORD DIAGNOSTICS
K800042 01/07/1980 LITHIUM STANDARD (1MM/L) GILFORD DIAGNOSTICS
K800043 01/07/1980 CESIUM DILUENT (1.5 MM/L) GILFORD DIAGNOSTICS
K800065 01/11/1980 ASI REAGENT GILFORD DIAGNOSTICS
K800120 01/18/1980 LDH (L-P) REAGENT GILFORD DIAGNOSTICS
K800341 02/15/1980 BUN REAGENT GILFORD DIAGNOSTICS
K810405 02/18/1981 CHOLESTEROL REAGENT GILFORD DIAGNOSTICS
K820975 04/06/1982 GILCHEM ACID PHOSPHATASE REAGENT GILFORD DIAGNOSTICS
K820976 04/06/1982 GIL CHEM MAGNESIUM REAGENT GILFORD DIAGNOSTICS
K790771 04/20/1979 LD-P REAGENT (LDH P-L REAGENT) GILFORD DIAGNOSTICS
K790786 04/23/1979 GLUCOSE (HK) REAGENT GILFORD DIAGNOSTICS
K800996 04/25/1980 HDL REAGENT GILFORD DIAGNOSTICS
K801012 04/28/1980 TRIGLYCERIDE REAGENT (COLOR) GILFORD DIAGNOSTICS
K831843 06/08/1983 GILCHEM TOTAL BILIRUBIN REAGENT GILFORD DIAGNOSTICS
K831844 06/08/1983 DIRECT BILIRUBIN REAGENT GILFORD DIAGNOSTICS
K821719 06/10/1982 AMMONIA REAGENT GILFORD DIAGNOSTICS
K811659 06/12/1981 CREATININE REAGENT GILFORD DIAGNOSTICS
K832094 06/28/1983 BILIRUBIN CALIBRATORS & CONTROL GILFORD DIAGNOSTICS
K811886 07/01/1981 CESIUM DILUENT 7.5M GILFORD DIAGNOSTICS
K791213 07/02/1979 GLUCOSE (GDH) REAGENT GILFORD DIAGNOSTICS
K801600 07/14/1980 GLUCOSE (TRINDER) REAGENT GILFORD DIAGNOSTICS
K822149 07/22/1982 GILCHEM Y-GT REAGENT GILFORD DIAGNOSTICS
K812109 07/27/1981 GILCHEM CREATININE REAGENT GILFORD DIAGNOSTICS
K812110 07/27/1981 GILCHEM CALCIUM REAGENT GILFORD DIAGNOSTICS
K822289 08/02/1982 CO2/CI STANDARDS GILFORD DIAGNOSTICS
K822334 08/04/1982 BILIRUBIN CALIBRATORS GILFORD DIAGNOSTICS
K791708 08/28/1979 INORGANIC PHOSPHORUS REAGENT GILFORD DIAGNOSTICS
K791725 08/31/1979 CHOLINESTERASE REAGENT GILFORD DIAGNOSTICS
K791754 09/05/1979 URIC ACID REAGENT GILFORD DIAGNOSTICS
K822739 09/09/1982 AHBD GILFORD DIAGNOSTICS
K791874 09/21/1979 CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD GILFORD DIAGNOSTICS
K792046 10/12/1979 URIC ACID STANDARD GILFORD DIAGNOSTICS
K781773 10/13/1978 ALBUMIN REAGENT GILFORD DIAGNOSTICS
K781774 10/13/1978 TOTAL PROTEIN GILFORD DIAGNOSTICS
K781775 10/13/1978 LDH GILFORD DIAGNOSTICS
K812861 10/13/1981 CHOLESTEROL CALIBRATORS GILFORD DIAGNOSTICS
K781782 10/19/1978 BUN GILFORD DIAGNOSTICS
K781783 10/19/1978 BLOOD SUGAR GILFORD DIAGNOSTICS
K781784 10/19/1978 AST GILFORD DIAGNOSTICS
K812912 10/19/1981 GILCHEM ALP REAGENT GILFORD DIAGNOSTICS
K802631 10/23/1980 CREATININE STANDARDS GILFORD DIAGNOSTICS
K802632 10/23/1980 ALBUMIN/TOTAL PROTEIN STANDARDS GILFORD DIAGNOSTICS
K802633 10/23/1980 BUN/GLUCOSE STANDARDS GILFORD DIAGNOSTICS
K813478 12/01/1981 TRIGLYCERIDE CALIBRATORS GILFORD DIAGNOSTICS
K823709 12/09/1982 TRIGLYCERIDE REAGENT (UV) GILFORD DIAGNOSTICS
K792605 12/18/1979 CHLORIDE REAGENT GILFORD DIAGNOSTICS
K803301 12/30/1980 CREATINE KINASE REAGENT GILFORD DIAGNOSTICS


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