FDA.reportPublic FDA data

510(k) K960366

Device
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
Applicant
ACCUMED INTL., INC.
510(k) number
K960366
Product code
LTT  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-09
Date received
1996-01-25
Regulation
866.1640
Classification name
Panels, Test, Susceptibility, Antimicrobial
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
REBECCA D FIELDS
Address
29299 Clemens Rd. Suite 1k Westlake OH US 44145 44145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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