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LAN — Enzyme Immunoassay, N-Acetylprocainamide Class II

FDA Device Classification

Classification Details

Product Code
LAN
Device Class
Class II
Regulation Number
862.3320
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060738roche diagnosticsTDM N-ACETYLPROCAINAMIDEAugust 16, 2006
K032564dade behringDIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111October 31, 2003
K011620syva co., dade behringEMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229June 18, 2001
K983812diagnostic reagentsNAPA EIA ASSAYNovember 16, 1998
K971713bayerN-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMJune 11, 1997
K955422abbott laboratoriesAXSYM N-ACETYLPROCAINAMIDEApril 24, 1996
K934705pb diagnostic systemsOPUS NAPANovember 22, 1993
K922915syvaEMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRATAugust 24, 1992
K895571tudor laboratoriesN-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITOctober 25, 1989
K873349em diagnostic systemsEASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649September 22, 1987
K871680roche diagnostic systemsMODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATORJune 8, 1987
K860140american dadeSTRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.February 6, 1986
K853547american dadeSTRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME ISeptember 16, 1985
K852319roche diagnostic systemsCOBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORSJune 25, 1985
K851060syvaEMIT QST N-ACETYLPROCAINAMIDE ASSAYApril 5, 1985
K833378e.i. dupont de nemours and coN-ACETYLPROCAINAMIDE ACA-ANALYTICALDecember 27, 1983
K832098syvaN-ACETYLPROCAINAMIDE ASSAY FOR COBASAugust 12, 1983
K831399miles laboratoriesAMES TDA N-ACETYL-PROCAINAMIDE TESTJune 2, 1983
K830206abbott laboratoriesTDX N-ACETYLPROCAINAMIDEFebruary 18, 1983
K823129syvaADVANCE EMIT-CAD N-ACETYLPROCAINAMIDENovember 29, 1982