Product code LAR— Clinical Toxicology

FDA has cleared 25 devices under product code LAR between 1978 and 2006, filed by 15 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.

• 20061 clearance
• 20031 clearance
• 20011 clearance
• 19971 clearance
• 19964 clearances
• 19951 clearance
• 19942 clearances
• 19921 clearance
• 19871 clearance
• 19861 clearance
• 19852 clearances
• 19841 clearance
• 19833 clearances
• 19821 clearance
• 19812 clearances

• Syva Co.8 clearances
• Roche Diagnostic Systems, Inc.2 clearances
• Boehringer Mannheim Corp.2 clearances
• Abbott Laboratories2 clearances
• Syva Co., Dade Behring, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Pb Diagnostic Systems, Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Em Diagnostic Systems, Inc.1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance

• K060773 — ONLINE TDM PROCAINAMIDERoche Diagnostics Corp.·2006-08-23
• K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110Dade Behring, Inc.·2003-10-31
• K010812 — EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.·2001-04-13
• K971716 — PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.·1997-06-27
• K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAYBoehringer Mannheim Corp.·1996-10-29
• K962099 — CEDIA PROCAINAMIDE ASSAYBoehringer Mannheim Corp.·1996-08-27
• K962463 — PROCAINAMIDE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.·1996-08-14
• K955444 — ABBOTT AXSM PROCAINAMIDE ASSAYAbbott Laboratories·1996-04-02
• K951434 — OPUS PROCAINAMIDEBehring Diagnostics, Inc.·1995-07-03
• K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATORRoche Diagnostic Systems, Inc.·1994-12-02
• K934762 — OPUS PROCAINAMIDE TEST SYSTEMPb Diagnostic Systems, Inc.·1994-07-20
• K922914 — EMIT 2000 PROCAINAMIDE CALIBRATORSSyva Co.·1992-08-24
• K873350 — EASY-TEST EMIT PROCAINAMIDE (PROC) #16648Em Diagnostic Systems, Inc.·1987-09-29
• K860141 — STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.American Dade·1986-02-11
• K852320 — COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATORRoche Diagnostic Systems, Inc.·1985-07-09
• K851061 — EMIT QST PROCAINAMIDE ASSAYSyva Co.·1985-04-12
• K834464 — TDX PROCAINAMIDEAbbott Laboratories·1984-02-03
• K833384 — PROCAINAMIDE ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1983-12-27
• K832718 — EMIT CAD PROCAINAMIDE ASSAYSyva Co.·1983-09-12
• K831400 — AMES TDA PROCAINAMIDE TESTMiles Laboratories, Inc.·1983-06-02
• K823128 — ADVANCE EMIT CAD PROCAINAMIDE ASSAYSyva Co.·1982-11-29
• K811770 — EMIT-CAD PROCAINAMIDE ASSAYSyva Co.·1981-07-10
• K811034 — EMIT-CAD N-ACETYLPROCAINAMIDE ASSAYSyva Co.·1981-05-01
• K790403 — EMIT QUINIDINE ASSAYSyva Co.·1979-03-21
• K781382 — EMIT PROCAINAMIDE ASSAYSyva Co.·1978-10-17