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510(k) K851984

Device
LKB-WALLAC 1230 ARCUS FLUOROMETER
Applicant
LKB INSTRUMENTS, INC.
510(k) number
K851984
Product code
KHO  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-24
Date received
1985-05-07
Regulation
862.2560
Classification name
Fluorometer, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ED ZIOR
Address
9319 Gaither Rd. Gaithersburg MD US 20877 20877

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KHO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical Aps2012-01-20
K973547TRIAGE STATMETERBiosite Incorporated1998-01-13
K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.1997-06-27
K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.1996-10-18
K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.1995-11-22
K950415FLUOROSCAN NEONATALIsolab, Inc.1995-09-05
K935047AUTO DELFIAWallac OY1994-05-23
K930689AUTOBEAD THYROID UPTAKEBio-Chem Laboratory Systems, Inc.1993-11-10
K926131OPUS MAGNUM ANALYZERPb Diagnostic Systems, Inc.1993-06-07
K923021AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Corp.1992-07-21
K920888MICROLITE MICROTITER PLATE LUMINOMETER ML2200Dynatech Laboratories, Inc.1992-03-19
K913130STRATUS IINTELLECT IMMUNOASSAY SYSTEMBaxter Healthcare Corp1991-09-27
K901674AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Corp.1990-05-02
K895240DELFIA PLATE FLUOROMETER 1232Pharmacia, Inc.1989-10-04
K894159OPUS IMMUNOASSAY SYSTEMPb Diagnostic Systems, Inc.1989-08-03

Legacy Summary#

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FDA Review#

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