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Aca(R) Urine Phencyclidine (U Pcp) Screen Method

by E.I. Dupont DE Nemours & Co., Inc.

510(k) K911725

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

A comprehensive, enzyme immunoassay for the detection of phencyclidine in urine, used to screen for substance abuse and addiction.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911725 Date3 Jun 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LCM
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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