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510(k) K852319

Device
Cobas Fp Reagents For Napa And Napa Calibrators
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K852319
Product code
LAN
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-25
Date received
1985-05-31
Regulation
862.3320
Classification name
Enzyme Immunoassay, N-Acetylprocainamide
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DONALD KAFADER
Address
Nutley NY US 07110 07110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K955422AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories1996-04-24
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
K851060EMIT QST N-ACETYLPROCAINAMIDE ASSAYSyva Co.1985-04-05
K833378N-ACETYLPROCAINAMIDE ACA-ANALYTICALE.I. Dupont DE Nemours & Co., Inc.1983-12-27