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510(k) K032573

Device
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
Applicant
DADE BEHRING, INC.
510(k) number
K032573
Product code
LAR  
Decision
Substantially Equivalent (SESE)
Decision date
2003-10-31
Date received
2003-08-20
Regulation
862.3320
Classification name
Enzyme Immunoassay, Procainamide
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD M VAUGHT
Address
Glasgow Business Community; Bldg. 500 Mail Box 514 P.O. Box 6101, Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060773ONLINE TDM PROCAINAMIDERoche Diagnostics Corp.2006-08-23
K010812EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.2001-04-13
K971716PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.1997-06-27
K963306CEDIA N-ACETYLPROCAINAMIDE ASSAYBoehringer Mannheim Corp.1996-10-29
K962099CEDIA PROCAINAMIDE ASSAYBoehringer Mannheim Corp.1996-08-27
K962463PROCAINAMIDE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1996-08-14
K955444ABBOTT AXSM PROCAINAMIDE ASSAYAbbott Laboratories1996-04-02
K951434OPUS PROCAINAMIDEBehring Diagnostics, Inc.1995-07-03
K942847COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATORRoche Diagnostic Systems, Inc.1994-12-02
K934762OPUS PROCAINAMIDE TEST SYSTEMPb Diagnostic Systems, Inc.1994-07-20
K922914EMIT 2000 PROCAINAMIDE CALIBRATORSSyva Co.1992-08-24
K873350EASY-TEST EMIT PROCAINAMIDE (PROC) #16648Em Diagnostic Systems, Inc.1987-09-29
K860141STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.American Dade1986-02-11
K852320COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATORRoche Diagnostic Systems, Inc.1985-07-09
K851061EMIT QST PROCAINAMIDE ASSAYSyva Co.1985-04-12

Legacy Summary#

summary

FDA Review#

Decision Summary