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Revised Labeling for Syva Propoxyphene Assays

by Syva Co. 510(k)

Active United States

510(k) K874200

Overview

This device is an Enzyme Immunoassay for Propoxyphene, as defined by its device name and product code JXN. It is a Class II medical device under regulation number 862.3700, with special controls in the Clinical Toxicology specialty. The device received traditional 510(k) clearance as substantially equivalent (SESE) on October 28, 1987, under K874200.

It was manufactured by Syva Co. located in Palo Alto, California, and is identified by multiple FEI and registration numbers. The device is intended for use in clinical toxicology settings for the detection of propoxyphene. No information is provided regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874200 Date28 Oct 1987ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JXN
Device Class
Class II
Regulation
21 CFR Part 862.3700
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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