Cleared Traditional

STRATUS LIDOCAINE FLUOROMETRIC ENZYME

K843184 · American Dade · Immunology
Sep 1984
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K843184 is an FDA 510(k) clearance for the STRATUS LIDOCAINE FLUOROMETRIC ENZYME, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984, 44 days after receiving the submission on August 13, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 862.3555.

Submission Details

510(k) Number K843184 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1984
Decision Date September 26, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
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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