FDA.reportPublic FDA data

510(k) K782143

Device
RIA KIT, GLUCOSE
Applicant
SERONO LABORATORIES, INC.
510(k) number
K782143
Product code
JME  
Decision
Substantially Equivalent (SESE)
Decision date
1979-02-22
Date received
1978-12-27
Regulation
862.1335
Classification name
Radioimmunoassay, Glucagon
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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893975DOUBLE ANTIBODY GLUCAGONDiagnostic Products Corp.1989-10-31
K771948GLUCAGON RIA MODULEInter Science Institute1978-01-20

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