Cleared Traditional

ONLINE DAT PROPOXYPHENE PLUS

K043303 · Roche Diagnostics Corp. · Toxicology
Mar 2005
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K043303 is an FDA 510(k) clearance for the ONLINE DAT PROPOXYPHENE PLUS, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on March 11, 2005, 101 days after receiving the submission on November 30, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K043303 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2004
Decision Date March 11, 2005
Days to Decision 101 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXN — Enzyme Immunoassay, Propoxyphene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3700

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