FDA.reportPublic FDA data

510(k) K932122

Device
BIOMIC VIDEO PLATE READER
Applicant
GILES SCIENTIFIC, INC.
510(k) number
K932122
Product code
KZK  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-01
Date received
1993-05-03
Regulation
866.2850
Classification name
Reader, Zone, Automated
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID L GIBBS
Address
250 Mercer St. Suite A301 New York NY US 10012 10012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KZK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991473SIRSCANIntelligence Artificielle Applications1999-11-23
K944319BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEMGiles Scientific, Inc.1994-12-15

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