QMS CARBAMAZEPINE ASSAY— 510(k) K940374

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K940374 for QMS CARBAMAZEPINE ASSAY, Substantially Equivalent on 1994-06-02. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1994-01-26
Decision date: 1994-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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