Cleared Traditional

TDX(R)/TDXFLX(R) FREE PHENYTOIN II

K950280 · Abbott Laboratories · Toxicology
May 1995
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K950280 is an FDA 510(k) clearance for the TDX(R)/TDXFLX(R) FREE PHENYTOIN II, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) (Class II — Special Controls, product code MOJ), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 2, 1995, 98 days after receiving the submission on January 24, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K950280 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1995
Decision Date May 02, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Toxicology (TX)
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