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Propoxphene Eia Test

by Diagnostic Reagents, Inc. 510(k)

Active United States

510(k) K943414

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943414 Date9 Sep 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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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