Chem-Elec, Inc.

Medical device manufacturer in North Webster, IN.

9510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K943503Chemcard Glucose TestCGA · Traditional 07/23/1996SE
K864159Solid Phase Deter Serum Cholesterol FR Whole BloodCHH · Traditional 06/10/1988SE
K811406Creatinine Rate Reagent KitCGX · Traditional 08/13/1981SE
K811381AstraJFL · Traditional 08/13/1981SE
K811319Chloride Reagent KitJFS · Traditional 08/13/1981SE
K811165Glucose Oxidase Rate ReagentCGA · Traditional 08/13/1981SE
K811310Sodium/Potassium Reagent KitsCEM · Traditional 07/10/1981SE
K811193Bun Rate ReagentCDS · Traditional 07/10/1981SE
K811701Chloride/Carbon Dioxide Rate ReagentJFS · Traditional 07/01/1981SE