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510(k) K790791

Device
ELECTROPHORESIS REAGENT SET, HDL
Applicant
GELMAN SCIENCES, INC.
510(k) number
K790791
Product code
LBT  
Decision
Substantially Equivalent (SESE)
Decision date
1979-06-15
Date received
1979-04-24
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
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0Morax1999-06-18
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

Legacy Summary#

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FDA Review#

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