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Biorent Diagnostic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K832747ALBUMIN REAGENT SETOctober 14, 1983
K823060HEMOGLOBIN REAGENTNovember 22, 1982
K823211CK-UV REAGENTNovember 22, 1982
K822493OPTIMIZED UV-GOT REAGENT SETSeptember 21, 1982
K822494OPTIMIZED UV-GPT REAGENT SETSeptember 21, 1982
K822492OPTIMIZED UV-LDH REAGENT SETSeptember 17, 1982
K820768COLORIMETRIC LDH REAGENT SETApril 14, 1982
K820632COLORIMETRIC URIC ACID REAGENT SETMarch 25, 1982
K813555GLUCOSE ENZYME-COLOR REAGENT SETJanuary 18, 1982
K813244UV URIC ACID DETERMINATIONDecember 8, 1981
K811760CHOLESTEROL DETERMINATIONJuly 10, 1981