Cleared Traditional

AXSYM PHENYTOIN II

K953840 · Abbott Laboratories · Toxicology

Sep 1995

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K953840 is an FDA 510(k) clearance for the AXSYM 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 September 25, 1995, 40 days after receiving the submission on August 16, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K953840 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1995
Decision Date	September 25, 1995
Days to Decision	40 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