Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Colony Laboratories, Inc. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

67 daysmedian FDA review time

70 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K894523	FPR GENTAMICIN KIT	Colony Laboratories, Inc.	1989-09-28	70
K894517	FPR AMIKACIN KIT	Colony Laboratories, Inc.	1989-09-28	70
K894524	FPR GENTAMICIN CALIBRATOR KIT	Colony Laboratories, Inc.	1989-09-28	70
K894518	FPR AMIKACIN CALIBRATOR KIT	Colony Laboratories, Inc.	1989-09-28	70
K894521	FPR DIGOXIN KIT	Colony Laboratories, Inc.	1989-09-25	67
K894528	FPR PHENYTOIN CALIBRATOR KIT	Colony Laboratories, Inc.	1989-09-25	67
K894527	FPR PHENYTOIN KIT	Colony Laboratories, Inc.	1989-09-25	67
K894522	FPR DIGOXIN CALIBRATOR KIT	Colony Laboratories, Inc.	1989-09-25	67
K894530	FPR THEOPHYLLINE CALIBRATOR KIT	Colony Laboratories, Inc.	1989-09-18	60
K894529	FPR THEOPHYLLINE KIT	Colony Laboratories, Inc.	1989-09-15	57
K894531	FPR TOBRAMYCIN KIT	Colony Laboratories, Inc.	1989-09-01	43
K894532	FPR TOBRAMYCIN CALIBRATOR KIT	Colony Laboratories, Inc.	1989-09-01	43
K894520	FPR CARBAMAZEPINE CALIBRATOR KIT	Colony Laboratories, Inc.	1989-08-28	39
K894526	FPR PHENOBARBITAL CALIBRATOR KIT	Colony Laboratories, Inc.	1989-08-28	39
K894525	FPR PHENOBARBITAL KIT	Colony Laboratories, Inc.	1989-08-28	39
K894519	FPR CARBAMAZEPINE KIT	Colony Laboratories, Inc.	1989-08-28	39

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda