Cleared Traditional

LIDOCAINE EIA ASSAY

K973102 · Diagnostic Reagents, Inc. · Toxicology
Sep 1997
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K973102 is an FDA 510(k) clearance for the LIDOCAINE EIA ASSAY, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 12, 1997, 24 days after receiving the submission on August 19, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3555.

Submission Details

510(k) Number K973102 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1997
Decision Date September 12, 1997
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KLR — Enzyme Immunoassay, Lidocaine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3555

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