FDA.reportPublic FDA data

510(k) K801143

Device
VOLU-SOL URINARY DICHROME STAIN
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K801143
Product code
IDA  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-30
Date received
1980-05-18
Regulation
864.1850
Classification name
Alcian Blue
Medical specialty
Hematology
Review panel
Pathology
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 IDA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832496BIO SURE STAINHelena Laboratories1983-09-12

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