Cleared Traditional

COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS

K941440 · Roche Diagnostic Systems, Inc. · Toxicology
Jul 1994
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K941440 is an FDA 510(k) clearance for the COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS, a Enzyme Immunoassay, Quinidine (Class II — Special Controls, product code LBZ), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 6, 1994, 104 days after receiving the submission on March 24, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K941440 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1994
Decision Date July 06, 1994
Days to Decision 104 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LBZ — Enzyme Immunoassay, Quinidine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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