FDA.reportPublic FDA data

510(k) K760826

Device
Histoplasma Mycelial Antigen
Applicant
I M, INC.
510(k) number
K760826
Product code
GMJ
Decision
Substantially Equivalent (SESE)
Decision date
1976-11-01
Date received
1976-10-13
Regulation
866.3320
Classification name
Antigens, Histoplasma Capsulatum, All
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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GMJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830837LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.1983-05-05
K813359MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLAmerican Scientific Products1981-12-31
K802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMNolan Biological Laboratories, Inc.1980-09-26
K792701HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.1980-01-23
K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.1980-01-17
K792708HISTOPLASMA CAPSULATUM, MYCELIAL PHASEMeridian Diagnostics, Inc.1980-01-17
K792711HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.1980-01-17
K791384FUNGAL IMMUNODIFFUSION KIT #ID1001Immuno-Mycologics, Inc.1979-08-16
K791393HISTOPLASMA YEAST ANTI #CF10021XImmuno-Mycologics, Inc.1979-08-16
K791394HISTOPLASMA MYCELIAL #CF10020XImmuno-Mycologics, Inc.1979-08-16
K760827HISTOPLASMA YEAST ANTIGENI M, Inc.1976-11-01