Cleared Traditional

AXSYM PHENYTOIN ASSAY

K935375 · Abbott Laboratories · Toxicology

Jun 1994

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K935375 is an FDA 510(k) clearance for the AXSYM PHENYTOIN ASSAY, 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 June 21, 1994, 225 days after receiving the submission on November 8, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K935375 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 1993
Decision Date	June 21, 1994
Days to Decision	225 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