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

KLB — Predicate Candidate Screening

23 FDA 510(k) clearances under this product code; the 50 most recent screened below.

29 daysmedian FDA review time

83 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060853	ONLINE TDM TOBRAMYCIN	Roche Diagnostics Corp.	2006-06-09	72	2
K012312	IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6	Diagnostic Products Corp.	2001-08-20	28	0
K003341	EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS	Syva Co., Dade Behring, Inc.	2001-01-22	89	0
K904304	DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD	E.I. Dupont DE Nemours & Co., Inc.	1990-10-26	37	0
K903192	IL TOBRAMYCIN ASSAY	Instrumentation Laboratory CO	1990-08-22	34	0
K893913	TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD	Technicon Instruments Corp.	1989-08-21	83	0
K882294	EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY	Syva Co.	1988-07-01	29	0
K874223	EMIT TOBRAMYCIN ASSAY	Syva Co.	1987-11-13	28	0
K854184	IN-VITRO TEST DETERMINATION OF TOBRAMYCIN	Clinical Data, Inc.	1985-12-04	50	0
K852671	ACA TOBRAMY-CIN ANALYTICAL TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1985-07-22	28	0
K832763	TOBRAMYCIN REAGENT	Biosan Laboratories, Inc.	1984-03-23	220	0
K832985	TOBRAMYCIN ANALYTICAL TEST PACK-ACA	E.I. Dupont DE Nemours & Co., Inc.	1983-10-27	55	0
K822858	COAT-A-COUNT TOBRAMYCIN RIA KIT	Diagnostic Products Corp.	1982-10-18	21	0
K813516	MRI TOBRAMYCIN RIA KIT	Microanalytic Research, Inc.	1981-12-29	14	0
K812415	KALLESTAD ANTISERA TO TOBRAMYCIN	Kallestad Laboratories, Inc.	1981-09-09	9	0
K810597	MACRO-VUE CARD TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-03-17	11	0
K810011	GAMMA STICK 125-1 TOBRAMYCIN RIA KIT	Alpha Gamma Laboratory	1981-01-28	23	0
K800743	TOBRAMYCIN RIA KIT	Antibodies, Inc.	1980-04-16	13	0
K791596	FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY	Bio-Rad	1979-10-17	63	0
K791502	QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO	Bio-Rad	1979-09-04	27	0
K791435	AMES TDA/TOBRAMYCIN	Miles Laboratories, Inc.	1979-08-16	16	0
K780934	IN VITRO TOBRAMYCIN RIA KIT	Clinical Assays, Inc.	1978-08-14	67	0
K760967	TOBRAMYCIN RIA KIT	Diagnostic Products Corp.	1976-12-22	48	0

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