FDA.reportPublic FDA data

510(k) K860141

Device
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
Applicant
AMERICAN DADE
510(k) number
K860141
Product code
LAR  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-11
Date received
1986-01-14
Regulation
862.3320
Classification name
Enzyme Immunoassay, Procainamide
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KAREN DARCY
Address
P.O. Box 25101 Santa Ana CA US 92799 92799

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K032573DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110Dade Behring, Inc.2003-10-31
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
K852320COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATORRoche Diagnostic Systems, Inc.1985-07-09
K851061EMIT QST PROCAINAMIDE ASSAYSyva Co.1985-04-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases