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Windsor Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITOctober 28, 1987
K873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYSeptember 22, 1987
K871486(FPIA) ASSAY BUFFERMay 8, 1987
K870390PHENOBARBITAL (FPIA) CALIBRATOR KITApril 1, 1987
K870389DIGOXIN (FPIA) CALIBRATOR KITApril 1, 1987
K864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAYJanuary 5, 1987
K863625PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KITNovember 10, 1986
K863244AMIKACIN (FPIA) CALIBRATOR KITAugust 29, 1986
K862248AMIKACIN KIT (FPIA)August 4, 1986
K861770PHENYTOIN (FPIA) CALIBRATOR KITJune 25, 1986
K861769GENTAMICIN (FPIA) CALIBRATOR KITJune 25, 1986
K861768THEOPHYLLINE (FPIA) CALIBRATOR KITJune 25, 1986
K861891TOBRAMYCIN (FPIA) CALIBRATOR KITJune 25, 1986
K854392TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMUDecember 5, 1985
K852013GENTAMICIN KIT(FPIA)June 10, 1985
K842585THEOPHYLLINE KIT FLUORESCENCE POLARIZA-September 26, 1984
K842586PHENYTOIN KIT FLUORESCENCE POLARIZATIONSeptember 26, 1984
K811442KWIK-LAC BETA-LACTAMASE KITSJune 18, 1981
K811412NEISSERIA-KWIKJune 16, 1981