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510(k) K955422

Device
Axsym N-acetylprocainamide
Applicant
ABBOTT LABORATORIES
510(k) number
K955422
Product code
LAN
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-24
Date received
1995-11-28
Regulation
862.3320
Classification name
Enzyme Immunoassay, N-Acetylprocainamide
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GRACE LEMIEUX
Address
Dept: 09v8 Bldg: Ap5-2 100 Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LAN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.2006-08-16
K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.2003-10-31
K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.2001-06-18
K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.1998-11-16
K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.1997-06-11
K934705OPUS NAPAPb Diagnostic Systems, Inc.1993-11-22
K922915EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRATSyva Co.1992-08-24
K895571N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITTudor Laboratories, Inc.1989-10-25
K873349EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649Em Diagnostic Systems, Inc.1987-09-22
K871680MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATORRoche Diagnostic Systems, Inc.1987-06-08
K860140STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.American Dade1986-02-06
K853547STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME IAmerican Dade1985-09-16
K852319COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORSRoche Diagnostic Systems, Inc.1985-06-25
K851060EMIT QST N-ACETYLPROCAINAMIDE ASSAYSyva Co.1985-04-05
K833378N-ACETYLPROCAINAMIDE ACA-ANALYTICALE.I. Dupont DE Nemours & Co., Inc.1983-12-27