Cleared Special

EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229

K011920 · Syva Co., Dade Behring, Inc. · Toxicology
Jul 2001
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K011920 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Syva Co., Dade Behring, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 2, 2001, 12 days after receiving the submission on June 20, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K011920 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2001
Decision Date July 02, 2001
Days to Decision 12 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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