Cleared Traditional

QUINIDINE ENZYME IMMUNOASSAY

K964212 · Diagnostic Reagents, Inc. · Toxicology
Dec 1996
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K964212 is an FDA 510(k) clearance for the QUINIDINE ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 18, 1996, 57 days after receiving the submission on October 22, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K964212 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1996
Decision Date December 18, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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