FDA.reportPublic FDA data

510(k) K810261

Device
EUROCHIMA UREA NITROGEN
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K810261
Product code
CDL  
Decision
Substantially Equivalent (SESE)
Decision date
1981-02-10
Date received
1981-01-30
Regulation
862.1770
Classification name
Berthelot Indophenol, Urea Nitrogen
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
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 CDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTReagents Applications, Inc.1990-02-16
K893128STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010Stanbio Laboratory1989-07-25
K871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, Inc.1987-05-12
K864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.1987-01-13
K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.1986-11-24
K863076UREAFASTJ. D. Assoc.1986-09-09
K860154BUN (ENZYMATIC BERTHELOT) REAGENT SETSterling Diagnostics, Inc.1986-02-06
K831414COLORIMETRIC BUNBio-Analytics Laboratories, Inc.1983-06-16
K822237UREA NITROGEN REAGENT SET (MOD. BERTHELSterling Biochemical, Inc.1982-08-16
K801727DATA-ZYME UREA NITROGEN, COLORIMETRICData Medical Associates, Inc.1980-09-09
K800902BUN-COLOR 2, BLOOD UREA NITROGEN TESTSclavo, Inc.1980-06-09
K792417ELVI BLOOD UREA NITROGENVolu Sol Medical Industries1979-12-07
K781899UREA NITROGEN TESTWako Intl., Inc.1978-12-20
K781306UREA NITROGEN TEST KITAnalytical & Research Chemicals, Inc.1978-08-31
K761152S-UREA-N, IN VITRO DIAG FOR BUNAdvanced Biomedical Methods, Inc.1976-12-09

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