FDA.reportPublic FDA data

510(k) K230161

Device
ONLINE TDM Phenytoin - Free Phenytoin application
Applicant
Roche Diagnostics
510(k) number
K230161
Product code
MOJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-30
Date received
2023-01-20
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
Dr. Leslie Patterson
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

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
K952555COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLSRoche Diagnostic Systems, Inc.1995-07-31
K950280TDX(R)/TDXFLX(R) FREE PHENYTOIN IIAbbott Laboratories1995-05-02