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Litton Bionetics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K840417EBNA ACIF KITDecember 27, 1984
K834443ROTAVIRUS BIO-ENZABEAD SCREEN KITMarch 16, 1984
K831343CMV RQ BIO-ENZABEAD KITAugust 8, 1983
K822985EBV-M KITDecember 3, 1982
K821804RUBELLA RQ BIO-ENZABEAD KITSeptember 14, 1982
K801721HSV BIO-BEAD TITRATION KITSeptember 16, 1980
K801720TOXO BIO-BEAD TITRATION KITSeptember 16, 1980
K801722CMV BIO-BEAD TITRATION KITSeptember 16, 1980
K800789RUBELLA BIO-BEAD TITRATION KITJune 30, 1980
K791610RUBELLA BIO-BEAD SCREEN KITNovember 13, 1979
K791614HSV BIO-BEAD SCREEN KITNovember 13, 1979
K791611TOXO BIO-BEAD SCREEN KITNovember 13, 1979
K791618TORCH BIO-BEAD SCREEN KITNovember 13, 1979
K791612CMV BIO-BEAD SCREEN KITNovember 13, 1979
K780925EB-VCA, TEST, ANTIBODY, FLUORESCENTJune 22, 1978