FDA.reportPublic FDA data

510(k) K800493

Device
BACTOGEN-H. INFLUENZAE TYPE B
Applicant
ARMKEL, LLC.
510(k) number
K800493
Product code
GRO  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-04
Date received
1980-03-04
Regulation
866.3300
Classification name
Antisera, Fluorescent, All Types, Hemophilus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K851271LEGIONELLA CULTURE CONFIRMATIN KITGen-Probe, Inc.1985-07-08
K834067LEGIONELLA DIFFERENTIATION DISKRemel Co.1984-01-03
K802423PHADEBACT HAEMOPHILUS TESTPharmacia, Inc.1980-11-12

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