AXSYM CARBAMAZEPHINE— 510(k) K935374

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K935374 for AXSYM CARBAMAZEPHINE, Substantially Equivalent on 1994-06-21. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1993-11-08
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.