Modification to the Emit II Plus Cocaine Metabolite Assay

by Syva Co., Dade Behring, Inc.

510(k) K011162

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

510(k) K011162↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK011162	Date2 May 2001Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K011162
FDA Product Code: DIO

Device Class: Class II
Regulation: 21 CFR Part 862.3250
Advisory Committee: Clinical Toxicology
FDA Decision: SESE Substantially Equivalent

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