Cleared Traditional

ACS PHENYTOIN ASSAY

K955873 · Ciba Corning Diagnostics Corp. · Toxicology

Mar 1996

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K955873 is an FDA 510(k) clearance for the ACS PHENYTOIN ASSAY, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II — Special Controls, product code LGR), submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on March 11, 1996, 76 days after receiving the submission on December 26, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K955873 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 1995
Decision Date	March 11, 1996
Days to Decision	76 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