FDA.reportPublic FDA data

510(k) K792683

Device
BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K792683
Product code
JWW  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-23
Date received
1979-12-27
Regulation
866.3060
Classification name
Antigen, Cf, B. Dermatitidis
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 JWW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802128IMMUNODIFFUSSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.1980-09-26
K792680BLASTOMYCES DERMATITIDIS, ANTIGENMeridian Diagnostics, Inc.1980-01-17

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