Cleared Special

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

K011166 · Syva Co., Dade Behring, Inc. · Chemistry
May 2001
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K011166 is an FDA 510(k) clearance for the MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2001, 24 days after receiving the submission on April 16, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K011166 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2001
Decision Date May 10, 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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