Cleared Traditional

COBAS REAGENT FOR LIDOCAINE & CALIBRATORS

K853010 · Roche Diagnostic Systems, Inc. · Toxicology
Aug 1985
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K853010 is an FDA 510(k) clearance for the COBAS REAGENT FOR LIDOCAINE & CALIBRATORS, a Enzyme Immunoassay, Lidocaine (Class II — Special Controls, product code KLR), submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on August 7, 1985, 22 days after receiving the submission on July 16, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3555.

Submission Details

510(k) Number K853010 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1985
Decision Date August 07, 1985
Days to Decision 22 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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