Cleared Traditional

ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE

K922991 · Abbott Laboratories · Toxicology
Aug 1992
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K922991 is an FDA 510(k) clearance for the ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE, 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 27, 1992, 66 days after receiving the submission on June 22, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K922991 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1992
Decision Date August 27, 1992
Days to Decision 66 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

Similar Devices — LGS Fluorescence Polarization Immunoassay, Theophylline

All 12
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
K070810 · Biokit, S.A. · Jun 2007
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
K955567 · Oxis Intl., Inc. · Jan 1996
AXSYM THEOPHYLLINE II
K953016 · Abbott Laboratories · Aug 1995
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169 · Ciba Corning Diagnostics Corp. · Jun 1995
QMS THEOPHYLLINE CS
K942991 · Seradyn, Inc. · Sep 1994
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · Abbott Laboratories · Aug 1993