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Advanced Biomedical Methods, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K945353CLARIT(TM)December 9, 1994
K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERApril 5, 1988
K864866RESUBMISSION OF THE KLEERZIT REAGENTMarch 16, 1987
K852784ALKALINE PHOSPHATASEJuly 22, 1985
K852783SGOT/ALT REAGENTJuly 22, 1985
K852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZERMay 29, 1985
K850378LDH REAGENT FOR DEMAND ANALYZERMarch 1, 1985
K850379DIRECT BILIRUBIN FOR DEMAND ANALYZERMarch 1, 1985
K850381MAGNESIUM REAGENT FOR DEMAND ANALYZERMarch 1, 1985
K850380INORGANIC PHOSPHOROUS FOR DEMAND ANALYZERMarch 1, 1985
K844242CHOLESTEROL REAGENT FOR DEMAND ANALYZERJanuary 3, 1985
K844243TOTAL BILIRUBIN FOR DEMAND ANALYZERJanuary 3, 1985
K844241CALCIUM REAGENT FOR DEMAND ANALYZERJanuary 3, 1985
K844331TOTAL PROTEIN REAGENT FOR DEMAND ANALYZERJanuary 3, 1985
K844332CREATININE REAGENT FOR DEMAND ANALYZERJanuary 3, 1985
K844330ALBUMIN REAGENT FOR DEMAND ANALYZERJanuary 3, 1985
K844021ISE REAGENTS FOR DEMAND ANALYZERDecember 10, 1984
K771586CHOLOPAP-HDLSeptember 15, 1977
K761152S-UREA-N, IN VITRO DIAG FOR BUNDecember 9, 1976
K761153GLUC OPAP, IN VITRO DIAG. FOR GLUCOSEDecember 9, 1976