Cleared Traditional

CEDIA PROCAINAMIDE ASSAY

K962099 · Boehringer Mannheim Corp. · Toxicology
Aug 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K962099 is an FDA 510(k) clearance for the CEDIA PROCAINAMIDE ASSAY, a Enzyme Immunoassay, Procainamide (Class II — Special Controls, product code LAR), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on August 27, 1996, 90 days after receiving the submission on May 29, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K962099 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1996
Decision Date August 27, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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