Cleared Special

ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

K013272 · Bayer Corp. · Chemistry
Oct 2001
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K013272 is an FDA 510(k) clearance for the ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 25, 2001, 24 days after receiving the submission on October 1, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K013272 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2001
Decision Date October 25, 2001
Days to Decision 24 days
Submission Type Special
Review Panel Chemistry (CH)
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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