Cleared Traditional

ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89

K993029 · Syva Co. · Toxicology
Jan 2000
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K993029 is an FDA 510(k) clearance for the ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000, 140 days after receiving the submission on September 9, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K993029 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1999
Decision Date January 27, 2000
Days to Decision 140 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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