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Worthington Diagnostic Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEJanuary 4, 1984
K832427EASYTOUCH TROMBOPLASTIN REAGENTOctober 14, 1983
K832785COMPUR* EASY TOUCH URIC ACID REAGENTOctober 14, 1983
K832749EASYTOUCH BUN REAGENT SETOctober 14, 1983
K832748COMPUR* EASYTOUCH TOTAL BILIRUBINOctober 14, 1983
K832750EASYTOUCH HEMOGLOBIN REAGENTSeptember 26, 1983
K832426EASYTOUCH TRIGLYCERIDES REAGENT SETSeptember 12, 1983
K831477DEMAND ANALYZER SYSTEMJune 17, 1983
K831318COMPUR* M1100 HEMATRCRIT SYSTEMJune 8, 1983
K831227COMPUR EASY TOUCH CHEMISTRY ANALYZER-June 2, 1983
K831101TIA-IGG REAGENT & CALIBRATOR SETSApril 27, 1983
K831102TIA-IGA REAGENT & CALIBRATOR SETSApril 27, 1983
K831103TIA-IGM REAGENT & CALIBRATOR SETSApril 27, 1983
K810997WORTHINGTON CK (NAC) REAGENT SETApril 23, 1981
K802573SERUM T4 BY ENZYME IMMUNOASSAYNovember 24, 1980
K800028WORTHINGTON FLOZYME* CPK (340NM)January 21, 1980
K791962WORTHINGTON TRIGLYCERIDES REAGENT SETNovember 5, 1979
K790474SZAMYL 6.5May 1, 1979
K790486FLOZYME* URIC ACID REAGENTApril 23, 1979