FDA.reportPublic FDA data

510(k) K973995

Device
RANDOX BILIRUBIN
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K973995
Product code
GIG  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-08
Date received
1997-10-21
Regulation
864.7500
Classification name
Hemoglobinometer
Medical specialty
Hematology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
P ARMSTRONG
Address
Ardmore, Diamond Rd. Crumlin IE BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933836HBM HEMOGLOBINOMETERArtel, Inc.1994-03-31
K771101HEMOGLOBIN ANALYZER & PERFORM. CHECK SETThe Dow Chemical Co.1977-07-21

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