Cleared Traditional

PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K971716 · Bayer Corp. · Chemistry
Jun 1997
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K971716 is an FDA 510(k) clearance for the PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, a Enzyme Immunoassay, Procainamide (Class II — Special Controls, product code LAR), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 27, 1997, 49 days after receiving the submission on May 9, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K971716 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1997
Decision Date June 27, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LAR — Enzyme Immunoassay, Procainamide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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