Emit Ii Plus Opiate Assay, Model OSR9B229

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

Active United States

510(k) K011289

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK011289	Date15 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Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number: K011289
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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