Product code LAN— Clinical Toxicology

FDA has cleared 21 devices under product code LAN between 1978 and 2006, filed by 14 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
• 19981 clearance
• 19971 clearance
• 19961 clearance
• 19931 clearance
• 19921 clearance
• 19891 clearance
• 19872 clearances
• 19861 clearance
• 19853 clearances
• 19834 clearances
• 19821 clearance
• 19781 clearance

• Syva Co.5 clearances
• Roche Diagnostic Systems, Inc.2 clearances
• American Dade2 clearances
• Abbott Laboratories2 clearances
• Tudor Laboratories, Inc.1 clearance
• 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

• K060738 — TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.·2006-08-16
• K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.·2003-10-31
• K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.·2001-06-18
• K983812 — NAPA EIA ASSAYDiagnostic Reagents, Inc.·1998-11-16
• K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.·1997-06-11
• K955422 — AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories·1996-04-24
• K934705 — OPUS NAPAPb Diagnostic Systems, Inc.·1993-11-22
• K922915 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRATSyva Co.·1992-08-24
• K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITTudor Laboratories, Inc.·1989-10-25
• K873349 — EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649Em Diagnostic Systems, Inc.·1987-09-22
• K871680 — MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATORRoche Diagnostic Systems, Inc.·1987-06-08
• K860140 — STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.American Dade·1986-02-06
• K853547 — STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME IAmerican Dade·1985-09-16
• K852319 — COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORSRoche Diagnostic Systems, Inc.·1985-06-25
• K851060 — EMIT QST N-ACETYLPROCAINAMIDE ASSAYSyva Co.·1985-04-05
• K833378 — N-ACETYLPROCAINAMIDE ACA-ANALYTICALE.I. Dupont DE Nemours & Co., Inc.·1983-12-27
• K832098 — N-ACETYLPROCAINAMIDE ASSAY FOR COBASSyva Co.·1983-08-12
• K831399 — AMES TDA N-ACETYL-PROCAINAMIDE TESTMiles Laboratories, Inc.·1983-06-02
• K830206 — TDX N-ACETYLPROCAINAMIDEAbbott Laboratories·1983-02-18
• K823129 — ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDESyva Co.·1982-11-29
• K781378 — EMIT N-ACETYLPROCAINAMIDE ASSAYSyva Co.·1978-10-10