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Ez-Screen:opiates

by Environmental Diagnostics, Inc. 510(k)

Active United States

510(k) K900203

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900203 Date9 Mar 1990ClearedStatusActive

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  • Withdrawn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
DJG
Device Class
Class II
Regulation
21 CFR Part 862.3650
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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