Cleared Traditional

IN VITRO TEST DETERMINATION OF THEOPHYLLINE

K854183 · Clinical Data, Inc. · Toxicology
Dec 1985
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K854183 is an FDA 510(k) clearance for the IN VITRO TEST DETERMINATION OF THEOPHYLLINE, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on December 19, 1985, 65 days after receiving the submission on October 15, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K854183 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1985
Decision Date December 19, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLS — Enzyme Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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