Cleared Traditional

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

K023795 · Lin-Zhi International, Inc. · Toxicology
Jan 2003
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K023795 is an FDA 510(k) clearance for the PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT), a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Lin-Zhi International, Inc. (San Jose, US). The FDA issued a Cleared decision on January 21, 2003, 69 days after receiving the submission on November 13, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K023795 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2002
Decision Date January 21, 2003
Days to Decision 69 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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