FDA.reportPublic FDA data

510(k) K782159

Device
DIAGNOSTIC KIT, FERRITAB-FE-59
Applicant
LEECO DIAGNOSTICS, INC.
510(k) number
K782159
Product code
JJA  
Decision
Substantially Equivalent (SESE)
Decision date
1979-02-01
Date received
1978-12-22
Regulation
862.1410
Classification name
Radio-labeled Iron Method, Iron (non-heme)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K820253SIMUL-FER SERUM IRON TEST KITDiagnostic Reagents, Inc.1982-05-12
K781769IRON 59 KITRia Products, Inc.1978-12-04
K760045KIT, RADIOASSAY, SERUM IRONBd Becton Dickinson Vacutainer Systems Preanalytic1976-07-20

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