Cleared Traditional

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641

K881116 · Diagnostic Systems · Toxicology
Jun 1988
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K881116 is an FDA 510(k) clearance for the EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on June 20, 1988, 97 days after receiving the submission on March 15, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3555.

Submission Details

510(k) Number K881116 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1988
Decision Date June 20, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

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