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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
K832748COMPUR* EASYTOUCH TOTAL BILIRUBINOctober 14, 1983
K832785COMPUR* EASY TOUCH URIC ACID REAGENTOctober 14, 1983
K832427EASYTOUCH TROMBOPLASTIN REAGENTOctober 14, 1983
K832749EASYTOUCH BUN REAGENT SETOctober 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
K831102TIA-IGA REAGENT & CALIBRATOR SETSApril 27, 1983
K831101TIA-IGG 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