Cleared Traditional

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET

K895827 · Innotron of Oregon, Inc. · Toxicology

Oct 1989

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K895827 is an FDA 510(k) clearance for the INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET, a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II — Special Controls, product code LGR), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on October 31, 1989, 29 days after receiving the submission on October 2, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number	K895827 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 1989
Decision Date	October 31, 1989
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

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