Cleared Traditional

AXSYM THEOPHYLLINE II

K953016 · Abbott Laboratories · Toxicology
Aug 1995
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K953016 is an FDA 510(k) clearance for the AXSYM THEOPHYLLINE II, a Fluorescence Polarization Immunoassay, Theophylline (Class II — Special Controls, product code LGS), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 24, 1995, 56 days after receiving the submission on June 29, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K953016 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1995
Decision Date August 24, 1995
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LGS — Fluorescence Polarization Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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