Modification to the Emit Ii Plus Methaqualone Assay, Model OSR9Q229

by Syva Co., Dade Behring, Inc. 510(k)

Active United States

510(k) K011164

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK011164	Date10 May 2001Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number: K011164
FDA Product Code: KXS

Device Class: Class II
Regulation: 21 CFR Part 862.3630
Advisory Committee: Clinical Toxicology
FDA Decision: SESE Substantially Equivalent

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