FDA.reportPublic FDA data

510(k) K830229

Device
ROENTGENOGRAPHY SET
Applicant
MALLINCKRODT CRITICAL CARE
510(k) number
K830229
Product code
DGD  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-09
Date received
1983-01-24
Regulation
866.5510
Classification name
Igg, Ferritin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DGD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K946266FERRITIN CONTROL - LEVEL 1, 2, 3Clinical Controls, Inc.1995-02-10
K881345IMX FERRITINAbbott Laboratories1988-05-11

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