Cleared Traditional

CEDIA N-ACETYLPROCAINAMIDE ASSAY

K963306 · Boehringer Mannheim Corp. · Toxicology
Oct 1996
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K963306 is an FDA 510(k) clearance for the CEDIA N-ACETYLPROCAINAMIDE 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 October 29, 1996, 68 days after receiving the submission on August 22, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K963306 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1996
Decision Date October 29, 1996
Days to Decision 68 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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