Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K993028 ↗

FDA Product Code

KLT

Models / Variants

Abbott Aeroset Carbamazepine Assay And Calibrators

Models 1E12 And 6E90

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Syva Co. →