Cleared Traditional

TURBOX THEOPHYLLINE ASSAY

K882570 · Unipath , Ltd. · Toxicology
Nov 1988
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K882570 is an FDA 510(k) clearance for the TURBOX THEOPHYLLINE ASSAY, a Fluorescent Immunoassay, Theophylline (Class II — Special Controls, product code LER), submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on November 10, 1988, 141 days after receiving the submission on June 22, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K882570 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1988
Decision Date November 10, 1988
Days to Decision 141 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LER — Fluorescent Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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