EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95— 510(k) K864553

Name: FDA 510(k) clearance K864553
Creator: U.S. Food and Drug Administration
Published: 1987-01-08

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K864553 for EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95, Substantially Equivalent on 1987-01-08. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1986-11-19
Decision date: 1987-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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