Medical Device Manufacturer · US , Washington , DC

Colony Laboratories, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1989

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Colony Laboratories, Inc. Toxicology ✕

16 devices

1-16 of 16

Cleared Sep 28, 1989

FPR AMIKACIN KIT

Toxicology · 70d

Cleared Sep 28, 1989

FPR AMIKACIN CALIBRATOR KIT

Toxicology · 70d

Cleared Sep 28, 1989

FPR GENTAMICIN KIT

Toxicology · 70d

Cleared Sep 28, 1989

FPR GENTAMICIN CALIBRATOR KIT

Toxicology · 70d

Cleared Sep 25, 1989

FPR DIGOXIN KIT

Toxicology · 67d

Cleared Sep 25, 1989

FPR DIGOXIN CALIBRATOR KIT

Toxicology · 67d

Cleared Sep 25, 1989

FPR PHENYTOIN KIT

Toxicology · 67d

Cleared Sep 25, 1989

FPR PHENYTOIN CALIBRATOR KIT

Toxicology · 67d

Cleared Sep 18, 1989

FPR THEOPHYLLINE CALIBRATOR KIT

Toxicology · 60d

Cleared Sep 15, 1989

FPR THEOPHYLLINE KIT

Toxicology · 57d

Cleared Sep 01, 1989

FPR TOBRAMYCIN KIT

Toxicology · 43d

Cleared Sep 01, 1989

FPR TOBRAMYCIN CALIBRATOR KIT

Toxicology · 43d

Cleared Aug 28, 1989

FPR CARBAMAZEPINE KIT

Toxicology · 39d

Cleared Aug 28, 1989

FPR CARBAMAZEPINE CALIBRATOR KIT

Toxicology · 39d

Cleared Aug 28, 1989

FPR PHENOBARBITAL KIT

Toxicology · 39d

Cleared Aug 28, 1989

FPR PHENOBARBITAL CALIBRATOR KIT

Toxicology · 39d