Cleared Traditional

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS

K864409 · Sclavo, Inc. · Toxicology
Dec 1986
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K864409 is an FDA 510(k) clearance for the IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS, a Fluorescent Immunoassay, Theophylline (Class II — Special Controls, product code LER), submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 22, 1986, 42 days after receiving the submission on November 10, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K864409 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 1986
Decision Date December 22, 1986
Days to Decision 42 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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