Cleared Traditional

PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

K943313 · Sigma Diagnostics, Inc. · Toxicology

Oct 1994

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K943313 is an FDA 510(k) clearance for the PHENYTOIN FPIA REAGENT SET AND CALIBRATORS, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II — Special Controls, product code LGR), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 27, 1994, 108 days after receiving the submission on July 11, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K943313 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1994
Decision Date	October 27, 1994
Days to Decision	108 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