FDA.reportPublic FDA data

510(k) K915700

Device
PERMIER HISTOPLASMA
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K915700
Product code
MIZ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-30
Date received
1991-12-23
Regulation
866.3320
Classification name
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALLEN D NICKOL
Address
3471 River Hills Dr. Cincinnati OH US 45244 45244

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MIZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102Immuno-Mycologics, Inc.2011-07-19

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