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Genchem, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3June 5, 2009
K040972CALCIUM, AZO DYE REAGENTDecember 27, 2004
K040974GLUCOSE OXIDASE, GLUCOSEDecember 27, 2004
K040973BUN REAGENTDecember 27, 2004
K040976GENCHEM CREATININE REAGENTDecember 27, 2004
K040975GENCHEM CO2 ACID REAGENTDecember 27, 2004
K040977GENCHEM ELECTROLYTE BUFFERDecember 27, 2004
K040971GENCHEM ISE ELECTROLYTE REFERENCEDecember 22, 2004