FDA 510(k) Applications Submitted by GENCHEM, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K040971 04/14/2004 GENCHEM ISE ELECTROLYTE REFERENCE GENCHEM, INC.
K040972 04/14/2004 CALCIUM, AZO DYE REAGENT GENCHEM, INC.
K040973 04/14/2004 BUN REAGENT GENCHEM, INC.
K040974 04/14/2004 GLUCOSE OXIDASE, GLUCOSE GENCHEM, INC.
K040975 04/14/2004 GENCHEM CO2 ACID REAGENT GENCHEM, INC.
K040976 04/14/2004 GENCHEM CREATININE REAGENT GENCHEM, INC.
K040977 04/14/2004 GENCHEM ELECTROLYTE BUFFER GENCHEM, INC.
K090283 02/05/2009 CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 GENCHEM, INC.


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