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Colony Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K894517FPR AMIKACIN KITSeptember 28, 1989
K894523FPR GENTAMICIN KITSeptember 28, 1989
K894524FPR GENTAMICIN CALIBRATOR KITSeptember 28, 1989
K894518FPR AMIKACIN CALIBRATOR KITSeptember 28, 1989
K894528FPR PHENYTOIN CALIBRATOR KITSeptember 25, 1989
K894521FPR DIGOXIN KITSeptember 25, 1989
K894522FPR DIGOXIN CALIBRATOR KITSeptember 25, 1989
K894527FPR PHENYTOIN KITSeptember 25, 1989
K894530FPR THEOPHYLLINE CALIBRATOR KITSeptember 18, 1989
K894529FPR THEOPHYLLINE KITSeptember 15, 1989
K894531FPR TOBRAMYCIN KITSeptember 1, 1989
K894532FPR TOBRAMYCIN CALIBRATOR KITSeptember 1, 1989
K894520FPR CARBAMAZEPINE CALIBRATOR KITAugust 28, 1989
K894525FPR PHENOBARBITAL KITAugust 28, 1989
K894519FPR CARBAMAZEPINE KITAugust 28, 1989
K894526FPR PHENOBARBITAL CALIBRATOR KITAugust 28, 1989