FDA.reportPublic FDA data

510(k) K850930

Device
GLUCOSE
Applicant
DILAB, INC.
510(k) number
K850930
Product code
CGE  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-10
Date received
1985-03-07
Regulation
862.1345
Classification name
Orthotoluidine, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RAFAEL A QUEVEDO
Address
7003 NW 50th St. Miami FL US 33166 33166

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.Alpkem Corp.1989-02-17
K855185GLUCOSE REAGENT SETTechnostics Intl.1986-01-22
K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.1984-05-01
K821198DIRECT GLUCOSE REAGENT SETOmega Medical Electronics1982-07-13
K811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, Inc.1981-07-23
K8100896% ORTHO LOLIUDINE REAGENT IN GLACID ACIAnco Medical Reagents & Assoc.1981-01-26
K790319ORTHO-TOLUIDINE REAGENT SETFisher Scientific Co., LLC1979-03-21
K781308GLUCOLOURAnalytical & Research Chemicals, Inc.1978-08-31
K771314GLUCOSE REAGENT (O-TOLUIDINE)Mallinckrodt Critical Care1977-08-03
K771091UNIPAK GLUCOSEHarleco1977-07-21
K770455GLUCOSE PROCEDURE, TEKPOINT DIRECTIcn Pharmaceuticals, Inc.1977-05-03

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