FDA.reportPublic FDA data

510(k) K990250

Device
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
Applicant
MORAX
510(k) number
K990250
Product code
LBT  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-18
Date received
1999-01-26
Regulation
862.1475
Classification name
Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BOREK JANIK
Address
13805 Waterloo Rd. Chelsea MI US 48118 48118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000568HDL CHOLESTEROL PLUSRoche Diagnostics Corp.2000-08-04
K972015HYDRAGEL 7,15,30, CHOL-HDL KITMorax1997-10-27
K904035REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEMHelena Laboratories1990-11-09
K894366REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187Helena Laboratories1989-08-31
K882368REP HDL ELECTROPHORESIS METHODHelena Laboratories1988-08-08
K873547TITAN GEL HDL CHOLESTEROL KITHelena Laboratories1987-10-02
K790791ELECTROPHORESIS REAGENT SET, HDLGelman Sciences, Inc.1979-06-15

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