FDA.reportPublic FDA data

510(k) K771243

Device
ANTISERA TO HUMAN FAB FRAGMENT
Applicant
Kent Laboratories, Inc.
510(k) number
K771243
Product code
DFK
Decision
Substantially Equivalent (SESE)
Decision date
1977-08-03
Date received
1977-07-11
Regulation
866.5520
Classification name
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
N

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 DFK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K790711ANTISERA TO HUMAN FRAGMENTKent Laboratories, Inc.1979-09-04
K770670FLOR. CONJUG. HUMAN FAB FRAGMENTKent Laboratories, Inc.1977-04-28