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Windsor Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K873281 CARBAMAZEPINE (FPIA) CALIBRATOR KITDLJ1987-10-28 View
510(k) K873282 CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYKLT1987-09-22 View
510(k) K871486 (FPIA) ASSAY BUFFERJJF1987-05-08 View
510(k) K870390 PHENOBARBITAL (FPIA) CALIBRATOR KITDLJ1987-04-01 View
510(k) K870389 DIGOXIN (FPIA) CALIBRATOR KITDLJ1987-04-01 View
510(k) K864333 DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAYKXT1987-01-05 View
510(k) K863625 PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KITLGQ1986-11-10 View
510(k) K863244 AMIKACIN (FPIA) CALIBRATOR KITDLJ1986-08-29 View
510(k) K862248 AMIKACIN KIT (FPIA)LGJ1986-08-04 View
510(k) K861769 GENTAMICIN (FPIA) CALIBRATOR KITJIS1986-06-25 View
510(k) K861768 THEOPHYLLINE (FPIA) CALIBRATOR KITJIS1986-06-25 View
510(k) K861770 PHENYTOIN (FPIA) CALIBRATOR KITJIS1986-06-25 View
510(k) K861891 TOBRAMYCIN (FPIA) CALIBRATOR KITJIS1986-06-25 View
510(k) K854392 TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMULFW1985-12-05 View
510(k) K852013 GENTAMICIN KIT(FPIA)LCQ1985-06-10 View
510(k) K842585 THEOPHYLLINE KIT FLUORESCENCE POLARIZA-LER1984-09-26 View
510(k) K842586 PHENYTOIN KIT FLUORESCENCE POLARIZATIONLGR1984-09-26 View
510(k) K811442 KWIK-LAC BETA-LACTAMASE KITS1981-06-18 View
510(k) K811412 NEISSERIA-KWIKJSX1981-06-16 View
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