FDA.reportPublic FDA data

510(k) K820368

Device
LECTIN-A
Applicant
AMERICAN DADE
510(k) number
K820368
Product code
KSI  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-14
Date received
1982-02-09
Regulation
864.9550
Classification name
Lectins And Protectins
Medical specialty
Hematology
Review panel
Hematology
Device class
2
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 KSI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K813413LECTIN HAmerican Dade1982-03-04
K792582POLY-LEC SYSTEMGamma Biologicals, Inc.1980-01-16
K792583GAMMA ARACHIS HYPOGEA LECTINGamma Biologicals, Inc.1980-01-16

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