FDA.reportPublic FDA data

510(k) K894712

Device
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
Applicant
GEN-PROBE, INC.
510(k) number
K894712
Product code
LQO  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-14
Date received
1989-07-26
Regulation
866.3110
Classification name
Dna-reagents, Campylobacter Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN F BRUNI,PHD
Address
9880 Campus Pt. Dr. San Diego CA US 92121 92121

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LQO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873670SNAP CAMPYLOBACTOR DIAGNOSTIC KITMolecular Biosystems, Inc.1988-06-08
K875101VIROGEN CMV ANTIBODY TESTWampole Laboratories1988-03-01
K863270GENE-TRAK CAMPYLOBACTER ASSAYIntegrated Genetics1987-08-31

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