Product code LBZ— Clinical Toxicology

FDA has cleared 27 devices under product code LBZ between 1981 and 2005, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20051 clearance
• 20041 clearance
• 20011 clearance
• 19963 clearances
• 19941 clearance
• 19921 clearance
• 19911 clearance
• 19901 clearance
• 19891 clearance
• 19872 clearances
• 19862 clearances
• 19851 clearance
• 19843 clearances
• 19834 clearances
• 19822 clearances

• Syva Co.7 clearances
• Abbott Laboratories3 clearances
• Roche Diagnostic Systems, Inc.2 clearances
• Innotron of Oregon, Inc.2 clearances
• Syva Co., Dade Behring, Inc.1 clearance
• Seradyn, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Oxis Intl., Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Em Diagnostic Systems, Inc.1 clearance

• K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.·2005-12-23
• K032332 — ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.·2004-01-12
• K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.·2001-06-12
• K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.·1996-12-24
• K964212 — QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.·1996-12-18
• K955568 — INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., Inc.·1996-04-04
• K941440 — COBAS-FP QUINIDINE REAGENTS AND CALIBRATORSRoche Diagnostic Systems, Inc.·1994-07-06
• K922913 — EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORSSyva Co.·1992-08-24
• K904990 — EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORSSyva Co.·1991-02-04
• K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATORInnotron of Oregon, Inc.·1990-04-12
• K892208 — INNOFLUOR(TM) QUINIDINE REAGENT SETInnotron of Oregon, Inc.·1989-06-09
• K872175 — TDXR FLECAINIDEAbbott Laboratories·1987-08-13
• K864607 — EASY-TEST QUINIDINE ITEM NO. 67---/95Em Diagnostic Systems, Inc.·1987-01-08
• K862214 — EMIT QUINIDINE ASSAYSyva Co.·1986-06-27
• K860049 — DETERMINATION OF QUINIDINEClinical Data, Inc.·1986-01-22
• K850808 — COBAS FP REAGENTS FOR QUINIDINERoche Diagnostic Systems, Inc.·1985-03-25
• K843237 — STRATUS QUINIDINE FLUOROMETRIC ENZYMEAmerican Dade·1984-09-12
• K842713 — TDX DISOPYRAMIDEAbbott Laboratories·1984-08-29
• K840596 — QUINIDINE ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1984-04-04
• K832493 — QUINIDINE FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.·1983-09-12
• K832096 — EMIT CAD QUINIDINE ASSAY FOR USE W/Syva Co.·1983-08-08
• K830963 — QUINIDINE REAGENT TEST KITBeckman Instruments, Inc.·1983-06-30
• K831355 — EMIT QST QUINIDINE ASSAYSyva Co.·1983-06-02
• K822653 — TDX QUINIDINEAbbott Laboratories·1982-09-28
• K822588 — ADVANCE EMIT-CAD QUINIDINE ASSAYSyva Co.·1982-09-17
• K812753 — AMES TDA QUINIDINE TESTMiles Laboratories, Inc.·1981-10-19
• K811460 — EMIT-CAD QUINIDINE ASSAYSyva Co.·1981-06-09