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

LCD — Predicate Candidate Screening

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

39 daysmedian FDA review time

193 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243500	ARCHITECT iGentamicin	Abbott Laboratories	2025-07-09	239	0
K102699	ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBR	Abbott Laboratories	2011-04-01	193	1
K060709	MULTIGENT GENTAMICIN	Seradyn, Inc.	2006-06-15	91	0
K042479	VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITRO	Ortho-Clinical Diagnostics, Inc.	2005-01-06	115	1
K020704	ROCHE ONLINE GENTAMICIN	Roche Diagnostics Corp.	2002-07-12	130	3
K012978	RANDOX GENTAMICIN	Randox Laboratories, Ltd.	2001-09-18	74	0
K012311	IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6	Diagnostic Products Corp.	2001-08-20	28	0
K010984	EMIT 2000 GENTAMICIN PLUS ASSAY	Syva Co., Dade Behring, Inc.	2001-04-20	18	0
K962819	GENTAMICIN FLEX REAGENT CARTRIDGE	Dade Intl., Inc.	1996-09-13	56	0
K962519	EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS	Behring Diagnostics, Inc.	1996-09-04	69	0
K953020	ACS GENTAMICIN	Ciba Corning Diagnostics Corp.	1995-08-02	34	0
K943982	IL TEST GENTAMICIN CALIBRATORS	Instrumentation Laboratory CO	1995-01-25	232	0
K935376	AXSYM GENTAMICIN	Abbott Mfg., Inc.	1994-06-21	225	1
K940376	QMS GENTAMICIN ASSAY	Seradyn, Inc.	1994-06-02	127	0
K913470	CEDIA(R) GENTAMICIN ASSAY	Microgenics Corp.	1991-09-27	53	0
K904305	DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD	E.I. Dupont DE Nemours & Co., Inc.	1990-10-15	26	0
K903743	IL GENTAMICIN ASSAY SYSTEM	Instrumentation Laboratory CO	1990-09-17	32	0
K900703	MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR	Innotron of Oregon, Inc.	1990-04-12	59	0
K895484	STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.	Baxter Healthcare Corp	1989-10-04	23	0
K893912	TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD	Technicon Instruments Corp.	1989-08-21	83	0
K874703	EMIT CONVENIENCE PACK: GENTAMICIN ASSAY	Syva Co.	1987-12-18	32	0
K873855	EMIT QST GENTAMICIN ASSAY	Syva Co.	1987-10-29	37	0
K873854	EMIT GENTAMICIN ASSAY	Syva Co.	1987-10-28	36	0
K871329	EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640	Em Diagnostic Systems, Inc.	1987-05-12	39	0
K862260	EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS	Syva Co.	1986-11-03	143	0
K860868	TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN	Technicon Instruments Corp.	1986-04-03	27	0
K860045	DETERMINATION OF GENTAMICIN	Clinical Data, Inc.	1986-01-22	16	0
K852672	ACA GENTAMICIN TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1985-08-02	39	0
K850060	DU PONT GENTAMICIN ASSAY REAGENTS	E.I. Dupont DE Nemours & Co., Inc.	1985-01-18	10	0
K832445	STRATUS GENTAMICIN FLUOROMETRIC ENZYM	American Dade	1983-08-31	37	0
K832056	EMIT AMD GENTAMICIN ASSAY	Syva Co.	1983-08-08	42	0
K831416	EMIT QST TOBRAMYCIN ASSAY	Syva Co.	1983-06-08	36	0
K831304	EMIT QST GENTAMICIN ASSAY	Syva Co.	1983-06-02	42	0
K823387	SOPHEIA GENTAMICIN EIA KIT	Diagnostic Products Corp.	1982-12-22	37	0
K811692	GENTAMICIN REAGENT TEST KIT	Beckman Instruments, Inc.	1981-07-15	30	0
K811744	VIRGO IPA FOR DETECTION OF GENTAMICIN	Electro-Nucleonics Laboratories, Inc.	1981-07-10	21	0
K800150	EMIT TOBRAMYCIN ASSAY	Syva Co.	1980-02-05	14	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