Cleared Traditional

ONLINE TDM Phenytoin - Free Phenytoin application

K230161 · Roche Diagnostics · Chemistry

Mar 2023

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K230161 is an FDA 510(k) clearance for the ONLINE TDM Phenytoin - Free Phenytoin application, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) (Class II — Special Controls, product code MOJ), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on March 30, 2023, 69 days after receiving the submission on January 20, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K230161 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 2023
Decision Date	March 30, 2023
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	MOJ — Fluorescence Polarization Immunoassay, Diphenylhydantoin (free)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3350