Emit 2000 Carbamazepine Assay, Model OSR4F229

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

Active United States

510(k) K010814

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK010814	Date13 Apr 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Withdrawn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: K010814
FDA Product Code: KLT

Device Class: Class II
Regulation: 21 CFR Part 862.3645
Advisory Committee: Clinical Toxicology
FDA Decision: SESE Substantially Equivalent

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