Cleared Traditional

QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K964116 · Bayer Corp. · Chemistry
Dec 1996
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K964116 is an FDA 510(k) clearance for the QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 24, 1996, 70 days after receiving the submission on October 15, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K964116 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1996
Decision Date December 24, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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