FDA.reportPublic FDA data

510(k) K811825

Device
ORANGE G-6
Applicant
SURGIPATH
510(k) number
K811825
Product code
HZH  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-10
Date received
1981-06-29
Regulation
864.1850
Classification name
Orange G
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 HZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842924ORANGE G, 1%E K Ind., Inc.1984-09-07
K822038VOLU-SOL ORANGE G-6(GILLS-MODVolu Sol Medical Industries1982-08-03
K800323VOLU-SOL ORANGE G-6 STAINVolu Sol Medical Industries1980-02-22

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