FDA.reportPublic FDA data

510(k) K950280

Device
Tdx(r)/tdxflx(r) Free Phenytoin Ii
Applicant
ABBOTT LABORATORIES
510(k) number
K950280
Product code
MOJ
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-02
Date received
1995-01-24
Regulation
862.3350
Classification name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DOUG KENTZ
Address
One Abbott Park Rd. D389, Ap30 Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230161ONLINE TDM Phenytoin - Free Phenytoin applicationRoche Diagnostics2023-03-30
K952555COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLSRoche Diagnostic Systems, Inc.1995-07-31