Cleared Traditional

THEOPHYLLINE KIT FLUORESCENCE POLARIZA-

K842585 · Windsor Laboratories, Inc. · Toxicology
Sep 1984
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K842585 is an FDA 510(k) clearance for the THEOPHYLLINE KIT FLUORESCENCE POLARIZA-, a Fluorescent Immunoassay, Theophylline (Class II — Special Controls, product code LER), submitted by Windsor Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984, 85 days after receiving the submission on July 3, 1984. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K842585 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1984
Decision Date September 26, 1984
Days to Decision 85 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

Similar Devices — LER Fluorescent Immunoassay, Theophylline

All 14
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
K942192 · Sigma Diagnostics, Inc. · Jul 1994
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521 · Microgenics Corp. · Dec 1990
TURBOX THEOPHYLLINE ASSAY
K882570 · Unipath , Ltd. · Nov 1988
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
K864409 · Sclavo, Inc. · Dec 1986
THEOFAST(TM) TEST PACKAGE
K863475 · 3M Company · Nov 1986
IMMPULSE THEOPHYLLINE ASSAY REAGENTS
K840758 · Paragon Diagnostics, Inc. · Apr 1984