Cleared Traditional

TDX(R)/TDXFLX(R) PHENYTOIN II

K946328 · Abbott Laboratories · Toxicology

Mar 1995

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K946328 is an FDA 510(k) clearance for the TDX(R)/TDXFLX(R) PHENYTOIN II, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II — Special Controls, product code LGR), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 28, 1995, 89 days after receiving the submission on December 29, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K946328 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 1994
Decision Date	March 28, 1995
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

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