Cleared Special

EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229

K011605 · Syva Co., Dade Behring, Inc. · Toxicology
Jun 2001
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K011605 is an FDA 510(k) clearance for the EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on June 12, 2001, 19 days after receiving the submission on May 24, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K011605 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2001
Decision Date June 12, 2001
Days to Decision 19 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LBZ — Enzyme Immunoassay, Quinidine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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