FDA.reportPublic FDA data

510(k) K842709

Device
IMMUSTAPH LATEX AGGLUTINATION KIT
Applicant
IMMUCELL CORP.
510(k) number
K842709
Product code
LHJ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-03
Date received
1984-07-12
Regulation
866.3700
Classification name
Staphylococcus Aureus Protein A Insoluble
Medical specialty
Microbiology
Review panel
Microbiology
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 LHJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940557STAPHYTECT-ODUnipath , Ltd.1994-07-28
K812181STAPHYLOCOCCAL PROTEIN A INSOLUBLEOxoid U.S.A., Inc.1981-08-25

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