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

LBZ — Predicate Candidate Screening

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

48 daysmedian FDA review time

104 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K052826	QMS QUINIDINE. QMS QUINIDINE CALIBRATORS	Seradyn, Inc.	2005-12-23	79
K032332	ROCHE ONLINE TDM QUINIDINE	Roche Diagnostics Corp.	2004-01-12	167
K011605	EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229	Syva Co., Dade Behring, Inc.	2001-06-12	19
K964116	QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO	Bayer Corp.	1996-12-24	70
K964212	QUINIDINE ENZYME IMMUNOASSAY	Diagnostic Reagents, Inc.	1996-12-18	57
K955568	INNOFLUOR QUINIDINE ASSAY SYSTEM	Oxis Intl., Inc.	1996-04-04	120
K941440	COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS	Roche Diagnostic Systems, Inc.	1994-07-06	104
K922913	EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS	Syva Co.	1992-08-24	68
K904990	EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS	Syva Co.	1991-02-04	90
K900705	MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR	Innotron of Oregon, Inc.	1990-04-12	59
K892208	INNOFLUOR(TM) QUINIDINE REAGENT SET	Innotron of Oregon, Inc.	1989-06-09	67
K872175	TDXR FLECAINIDE	Abbott Laboratories	1987-08-13	66
K864607	EASY-TEST QUINIDINE ITEM NO. 67---/95	Em Diagnostic Systems, Inc.	1987-01-08	45
K862214	EMIT QUINIDINE ASSAY	Syva Co.	1986-06-27	17
K860049	DETERMINATION OF QUINIDINE	Clinical Data, Inc.	1986-01-22	16
K850808	COBAS FP REAGENTS FOR QUINIDINE	Roche Diagnostic Systems, Inc.	1985-03-25	26
K843237	STRATUS QUINIDINE FLUOROMETRIC ENZYME	American Dade	1984-09-12	21
K842713	TDX DISOPYRAMIDE	Abbott Laboratories	1984-08-29	48
K840596	QUINIDINE ANALYTICAL TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1984-04-04	55
K832493	QUINIDINE FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1983-09-12	47
K832096	EMIT CAD QUINIDINE ASSAY FOR USE W/	Syva Co.	1983-08-08	40
K830963	QUINIDINE REAGENT TEST KIT	Beckman Instruments, Inc.	1983-06-30	94
K831355	EMIT QST QUINIDINE ASSAY	Syva Co.	1983-06-02	37
K822653	TDX QUINIDINE	Abbott Laboratories	1982-09-28	26
K822588	ADVANCE EMIT-CAD QUINIDINE ASSAY	Syva Co.	1982-09-17	22
K812753	AMES TDA QUINIDINE TEST	Miles Laboratories, Inc.	1981-10-19	20
K811460	EMIT-CAD QUINIDINE ASSAY	Syva Co.	1981-06-09	14

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