FDA.reportPublic FDA data

510(k) K020484

Device
CARESIDE LDH
Applicant
Careside, Inc.
510(k) number
K020484
Product code
CFH
Decision
Substantially Equivalent (SESE)
Decision date
2002-07-03
Date received
2002-02-13
Regulation
862.1440
Classification name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KENNETH B ASARCH
Address
6100 Bristol Pkwy. Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CFH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050790SPOTCHEM II LDH TESTArkray, Inc.2005-06-06
K895138CLINISTAT LDH REAGENT TESTHeraeus Kulzer, Inc.1989-10-19
K894578IQ LDHBd Becton Dickinson Vacutainer Systems Preanalytic1989-10-17
K880630LACTATE DEHYDROGENASE (LDH-L)Tech-Co, Inc.1988-03-16
K860349LACTATE DEHYDROGENASE (LDH) REAGENT SETSterling Diagnostics, Inc.1986-02-28
K852391EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDUREHelena Laboratories1985-10-01
K842452WAKO LDH CII TESTWako Chemicals USA, Inc.1984-08-15
K820768COLORIMETRIC LDH REAGENT SETBiorent Diagnostic, Inc.1982-04-14
K812836LDH REAGENT SETAnco Medical Reagents & Assoc.1981-10-09
K782176HYCEL LDH-INT TESTHycel, Inc.1979-01-26
K771343LDH-INT TESTHycel, Inc.1977-08-10
K760009COLORIMETRIC DETERMINATION (LDH)The Dow Chemical Co.1976-07-20